Quality & Regulatory Jobs in Pharma & Biotech

Shire Human Genetic Therapies, Inc. is seeking a Quality Control Analyst II with the following duties test biochemistry analytical methods for release and stability samples using qPCR (Quantitative Polymerase chain reaction), Kinetic Activity, Osmolality, Specific activity, Enzyme Activity, A280-320 protein concentration, pH, visual inspection and Reconstitution methodology. Provide subject matter expertise to junior level analyst in the lab. Proficiently use pH Meter, UV Spectrophotometer and solo VPE (Visual path extension), M5 and 384 Plate readers, 7500 fast Real-time PCR (Polymerase chain reaction) system and Osmometer. Provide support on maintenance of lab instruments in support of GMP (Good manufacturing Practices) testing....

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better...

About This Role As a Sr. Associate III, Quality Assurance (Quality Systems), you will play a pivotal role in ensuring the compliance and efficiency of quality systems at our Biogen RTP facility. Your expertise will be vital in overseeing Quality Control compliance of exceptions and CAPAs, contributing to the issuance and management of GMP documents, and supporting internal operations. This role is integral to maintaining GMP standards and will involve collaborating across functions to drive continuous improvement and global alignment. You'll be responsible for authoring key site reports and facilitating critical meetings and governance boards. Your contributions will support regulatory...

This position is responsible for providing investigation technical support, supplier process improvement, and scientific expertise and compliance knowledge to fulfill BMS requirements to implement supplier changes. Applicants must comply with Corporate and HR Policies, Security Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function Duties/Responsibilities Perform investigations, using eQMS (Infinity) system, for Supplier Complaints including but not limited to BMS and Supplier’s processes. Create and execute Corrective Actions and Preventive Actions (CAPA) Prepare, submit and discuss finding of the investigation process with key stakeholders. Lead global investigations in collaboration with Global Quality Supplier...

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Supplier Quality Engineer II to be located in Danvers, MA . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships...

Johnson & Johnson is currently seeking a Senior Manager, Source Regulatory Compliance to join our Regulatory Compliance team located in Irvine, CA; Plymouth, MN; Raynham, MA; or Miami, FL. Remote work options within the United States may be considered on a case-by-case basis and if approved by the company. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Please note that this role is available across multiple countries and may be posted under different requisition numbers to...

Johnson & Johnson is recruiting for a Senior Director, BWI Quality & Compliance to support our Cardiac Electrophysiology business. The role is based in Irvine, CA. POSITION SUMMARY Head of Quality, responsible for ensuring effective implementation of BWI Quality Management System. RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position Leads BWI Worldwide Quality functions, setting the strategies and goals in accordance with applicable regulatory requirements. Johnson and Johnson Enterprise, Medical Device and CSS policies and goals. Product Quality – Oversees directly and indirectly organization of Quality professionals,...

We are seeking a Principal Regulatory Affairs Specialist to join Abbott’s Vascular Division on-site in St. Paul, MN. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. The individual may...

This position works out of our Plano, TX location in the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. This role performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. What You’ll Work On Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. Records inspection and test data as prescribed by written instructions and procedures. Recommends changes...

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Perform validation testing, system administrator management, laboratory support and laboratory troubleshooting on laboratory instruments and computer systems. Plan, develop, and execute Installation Qualifications (IQ), Operation Qualifications (OQ), Performance Qualifications (PQ). Develop and execute validation and verification...

About the role This position holds ultimate responsibility for the overall Quality Assurance of Site Teardown and Fractionation Operations at Takeda’s Los Angeles Manufacturing Facility. The role is essential in ensuring that all quality-related activities meet regulatory standards and uphold Takeda’s commitment to excellence. The incumbent will work in close partnership with Manufacturing and Engineering Business Unit Leaders to ensure the timely implementation and ongoing maintenance of prevention-based Quality Systems. These systems include exception management, CAPA, Change Control, and Quality on the Shop Floor, all of which are critical to maintaining compliance and driving operational efficiency. Beyond quality oversight, the...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The intern candidate will be a member of Manufacturing Sciences, Analytics & Technology (MSAT), who's role is the technical guardian of manufacturing processes and technologies from product launch through their commercial manufacturing lifecycle. MSAT is known for its advanced expertise in Biotechnology, Chemistry, Pharmaceutical and Analytical Sciences, Process Design &...

As a Principal Regulatory Affairs Specialist at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies. You will provide strategic input and technical guidance to ensure our products meet evolving domestic and international regulatory requirements. This high-impact role involves leading regulatory submissions, maintaining compliance, and driving collaboration across teams to support product development and lifecycle management. Your expertise will directly influence patient access to life-changing therapies worldwide. Key Responsibilities Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering global regulations. Lead or perform coordination and...

We are seeking a strategic, experienced, and proactive Chief Compliance Officer (CCO) to lead and manage the global compliance and privacy functions for Medtronic Diabetes – a $2.8 billion medical device business that has recently announced that it will be spinning out into a standalone public company. Reporting to the company’s General Counsel, the CCO will be responsible for overseeing a comprehensive compliance program that ensures adherence to all applicable regulatory requirements, industry standards, ethical practices, and internal policies—across all regions of operation. The CCO will also lead the company’s global privacy team, ensuring compliance with global data protection regulations...

Use Your Power for Purpose At Pfizer, we are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer vaccines. By maintaining high standards and adapting to regulatory changes, you will play a key role in ensuring that our life-saving treatments reach those in need promptly and safely. What You Will Achieve ROLE SUMMARY This Director, Global...

Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures. Product information and labeling documentation contains the most accurate product use, benefits, dosage/application, and safety information, such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose The purpose of the Senior Director - Signal Management Group...

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Senior Supplier Quality Engineer to be located in Danvers, MA . About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Abiomed is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at #Li-Hybrid We are searching for the best talent for Quality Engineer 1 NPD to be in Irvine, California . The NPD Quality Engineer 1 executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product. Involved in NPD teams and other activities to develop products, design verification tests, process validations and...

About the Role The Quality Operations V role is responsible for ensuring the quality of processes and product outputs, aligning with regulatory standards and Takeda's quality practices. You will focus on defining activities, processes, and standards to meet quality requirements, auditing processes, and ensuring product integrity. Review batch records and disposition of finished good batches. Also, you will be responsible for batch folder creation and initiation. How you will Contribute Follow Standard Operating Procedures to build required work. Prepare metrics related to responsibilities/expertise and escalate issues and appropriate. Collaborate to improve Quality System processes. Must maintain oversight of assigned batch...

Senior Manager, Quality Engineering -- Minnetonka MN This position works out of our Minnetonka , MN location in the Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Senior Manager Quality Engineering , you’ll provide leadership and guidance for the quality engineering department supporting commercial products and new product development. This role is responsible for developing goals, objectives, procedures, policies, and systems that are in line with company goals and objectives, mission and...

Ensures quality control and quality assurance compliance across the manufacturing site. Serves as an integral member of QC leadership team with a focus on ensuring quality system requirements are achieved. Leads the site quality control unit and serves as the primary backup to the QC Head. Responsibilities Lead the biologics site Raw Materials and Incoming Materials laboratory processes and programs for a high volume, high level of product complexity including multi products to ensure compliance with regulations including EU Annex 1, FDA Guidalines, EMA, ANSI, among others. Ensure robustness and approves investigations Raw Materials & Incoming, quality and process excursions...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. R ESPONSIBILITIES Serve as a Lead Subject Matter Expert and Process Owner for assigned areas, processes, and technologies. Lead collaborations with CRO partners to ensure continuous improvement and alignment with Gilead’s RBQM framework, including representing RBQM in governance committees. Provide oversight of vendors performing RBQM activities, ensuring effective, high quality, and timely delivery of portfolio requirements. Support inspection-readiness and participate in audits and regulatory inspections, serving as a point of contact for RBQM. Study Risk Assessment and Mitigations Provide expert...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. At Medtronic Cardiac Ablation Solutions, our vision is to provide cardiac mapping and ablation solutions that will enable clinicians to treat patients more safely and efficiently, with more predictable procedure times and outcomes. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of...

Johnson & Johnson MedTech Research & Development Quality (RDQ) is recruiting for Clinical Supplier Quality Manager. The preferred locations are Raritan, NJ, Titusville, NJ, Bridgewater, NJ, West Chester, PA, Bridgewater, MA, Spring House, PA; Warsaw, IN, Raynham, MA; Jacksonville, FL, or Irvine, CA. However, the role can be performed at any location in the US. Remote work options may be considered on a case-by-case basis and if approved by the company. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help...

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). USA (Raritan, Titusville, New Brunswick, Horsham) Req # R-029353 Belgium (Beerse) Req # R-029496 Switzerland (Schaffhausen) Req # R-029503 Ireland (Cork) Req # R-029496 Netherlands (Leiden) Req # R-029496 The Senior Director, Quality Digital is responsible for defining and executing a comprehensive strategy that leverages digital transformation and advanced analytics...

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). USA (Raritan, Titusville, New Brunswick, Horsham) Req # R-029355 Belgium (Beerse) Req # R-029498 Switzerland (Schaffhausen) Req # R-029484 Ireland (Cork) Req # R-029498 The Vice President Quality Systems is responsible for providing high-level strategic oversight and direction for quality initiatives across the organization, including QMS, process ownership, capa/escalation and...

Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve. What You Will Achieve In this role, you will Lead...

Use Your Power for Purpose Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. What You Will Achieve In this role, you will Perform various chemical...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a...

This position works out of our Atlanta , Georgia location in the Heart Failure Division . In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Supervisor, Quality is responsible for the performance of his or her team and meeting any assigned project timelines and objectives. Keys to success include proper management of product support while ensuring quality and compliance of employees/equipment, promotion of a safe and positive work environment, constant pursuit of business excellence initiatives, successful management and development of...

This position works out of our Sylmar CA or Austin TX facily. What You’ll Work On Abbott is currently seeking an experienced professional to provide Provides direct oversight for moderately complex elements of Abbott’s compliance program at the franchise, business unit, regional, divisional, or corporate level. Responsible for directing the development and administration of OEC education and training, and development and implementation of divisional monitoring plan. Identifies compliance risk areas and recommends action plans to ECO or direct management. Responsible for direct compliance support of key business activities for the applicable business unit. Responsible for direct compliance support to e.g....

That’s what makes us Roche. The Opportunity As the site Data Integrity & Quality Governance Lead, you will be responsible for supporting the data integrity related programs governing compliance to all applicable regulations and guidances, both external and internal (e.g., 21 CFR 211, 21 CFR Part 11, EudraLex Volume 4 Part I, II and Annex 11, ICH Quality Guidelines, Industry Standards, GSP005, GSP006, Network and Local SOPs). You will be responsible for helping to provide oversight of the site data integrity program, and supporting initiatives with respect to data management, governance, integrity, issue resolution and quality. You will be responsible...

As a Quality Technical and Validation Manager, you will be responsible for overseeing the technical quality assurance and validation activities to ensure compliance with regulatory requirements, industry standards, and GSK policies. You will play a critical role in maintaining the highest levels of product quality and safety. This role leads a team that has responsibility and accountability for ensuring the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK's manufacturing and analytical environments. This includes overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of products from...

The Compliance Program Manager plays a critical role in ensuring the effective execution of Field Corrective Actions (FCA) across the organization. The role is responsible for overseeing the enterprise FCA planning process, ensuring compliance with quality system requirements, and driving continuous improvement in the FCA process. Additionally, the Compliance Program Manager will help to foster a culture of accountability and excellence while managing the end-to-end FCA process. This position demands a proactive approach to problem-solving, exceptional organizational skills, and a strong commitment to maintaining the highest standards of regulatory compliance and patient safety. Responsibilities may include the following and other...

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of...

Are you ready to help advance healthcare innovation? J&J is recruiting for a Global Design Lead (data design and process design), reporting into QC Operations in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for...

Quality Control Inspector II Structural Heart Business Mission Why We Exist Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. The Quality Control Inspector II provides an independent, unbiased evaluation of materials or the work of others. The results of the Inspector's evaluation is documented and communicated to organizational stakeholders with an interest in the evaluation's outcome - typically, this is supplier development and/ or manufacturing. The Inspector's approval certifies the work or material meets Abbott's quality system requirements. What You’ll Work On...

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. As a Supervisor Quality Assurance, main responsibility will include ensuring the quality standards and procedures are upheld in all site and operational processes. Role expectations will include leading a team in monitoring, evaluating, and improving operational efficiency and effectiveness while maintaining compliance with regulatory requirements and company standards. What You’ll...

Supplier Quality Engineer II This position works out of our Westfield, IN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. As the Supplier Quality Engineer II , you’ll be responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful, professional and effective manner. What You’ll Work On Supplier Audits Develop and execute to a...

This position works out of our Alameda, CA office in the Lingo Division. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. What You’ll Work...

What you will do In this role the Senior Engineer position reports to the Sr, Manager of Validation. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations in the Amgen Ohio facility. Functions The Senior Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Amgen Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply...

Job Responsibilities Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective/preventive actions Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions...

Sr. Quality Engineer will support day to day activities on manufacturing process. Support nonconformance investigations, audit process and CAPA process. Will oversee manufacturing and engineering processes to ensure proper use of tools, materials, and procedures. Developing and implementing quality control to analyze and improve existing systems. Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating...

As a member of Supplier Quality Engineering at Medtronic Energy and Component Center (MECC), you will be responsible for management of external suppliers to MECC. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. Responsibilities may include the following and other duties may be assigned. Ensure that suppliers deliver quality parts, materials, and services. Lead cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection....

J&J MedTech Surgery, a global leader in surgery with products and solutions found in almost every operating room around the world, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues so that people may live longer, healthier lives. Through our surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats, we deliver innovation to make a life-changing...

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and...

This position will work NIGHTS from 6 PM to 6 AM on a 2-2-3 rotation schedule About This Role The Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. Specifically, this role will have primary quality oversight of the following activities (1) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exceptions review and approval and (3) Respond to operational needs that require QA approval. What You’ll Do Ensures Product documentation and other...

Medtronic – Warsaw, IN manufactures spinal implants and Brain/ENT instrument components. In this exciting and fulfilling role the Quality Engineer will be responsible for providing quality support to the product value stream, ensuring that customer and patient needs are met every day. They will be part of a passionate team dedicated to ensuring our products meet the highest standards. The Quality Engineer II role is critical in supporting key department metrics, which contributes to the global strategy while delivering on our mission to manufacture products of the highest quality that alleviate pain, restore health and extend the life of our...

SR. ASSOCIATE QUALITY ASSURANCE - INSPECTION What will you do? In this role you will ensure the integrity and compliance of materials and processes that support the delivery of high-quality, life-impacting products. You’ll provide QA support in a Non-Standard Shift Operations environment that may include weekends and/or nights ensuring products meet the highest standards of compliance, safety, and quality. Specific responsibilities include but are not limited to Perform inspections, testing, and release activities independently, ensuring strict adherence to SOPs, cGMPs, and safety protocols. Apply subject matter expertise in materials and production processes to identify quality issues and ensure compliance. Accurately...

The Senior Quality Specialist will provide QA support for manufacturing operations, analytical laboratory operations, and materials management for the internal programs at Vertex Manufacturing Center (VMC), Boston, MA. The position will be a part of the QA operation floor support team. This role will review & support activities related to product disposition, including batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation. The Senior Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The position will support multiple production functions (from Quality operations...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. Grounded in core values Integrity, Collaboration, Innovation, Expertise. This critical role Covers all Lifecycle phases of pre-authorization to regulatory submission, submission to pre-approval inspection (PAI), PAI...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for a Quality Inspector I to be in Danvers, MA. Job Summary The Quality Inspector I will perform basic inspections and sorting of incoming materials, parts/components. Provide support as needed to the Operations group. Duties and Responsibilities Perform inspections of...

The Regulatory Affairs Director (RAD) , Global Regulatory Strategy will be responsible for the development and implement ation of global regulatory strategies for all assigned products and therapeutic areas, with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, lead cross-Regulatory teams and be accountable to provide key regulatory input to Global Program and/or Medicine Teams (GPTs/GMTs) deliverables . The individual will also ensure effective communication and constructive working relationships with business partners and representatives of...

We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Sylmar, CA or Scottsdale, AZ . As an individual contributor, the function of a Regulatory Affairs Specialist I is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for US and international registration assessments. What You’ll Work On Annual Reports – FDA APRs, ARCs (support), Custom Devices, Ics (support)...

Senior Development Quality Manager This position works out of our Menlo Park, CA location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a passionate Senior Development Quality Manager to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring...

Quality Manager, Enterprise Systems As a Quality Manager, Enterprise Systems , you will be responsible for planning, directing and coordinating quality and enterprise systems programs within Abbott’s Rapid & Molecular Diagnostics (RMDx) Infectious Disease (ID) business unit. This role is chiefly focused on business and stakeholder engagement, business and enterprise systems change management, strategic planning, communications and Quality program delivery. The Quality Manager, Enterprise Systems will champion the Quality function ensuring that the ID QA initiatives are aligned to business strategy. This role will interact with divisional leaders, RMDx shared service leads, BTS Business Relationship Managers and IT...

Pfizer Sanford provides Drug Substance and Drug products to facilities around the globe. This position will write, or support the development of, various technical documents such as standard operating procedures, executable electronic forms, specifications, and business guidance documents. The candidate will assist in Pfizer's digital revolution by representing the department in transformation of protocols, plans, reports, forms and other documentation to electronic documents. Additionally, the candidate will help lead continuous improvement projects within the validation department. As an associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will...

About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson is recruiting for a Staff Software Quality Engineer , located in Santa Clara, CA. Our team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing...

Johnson & Johnson is currently recruiting for a Senior Manager, Quality Systems! This position can be located at any US/PR J&J site with a preference for Horsham, PA, Titusville or Raritan, NJ. Senior Manager External Quality, P&O is the EQ Global Process Team Leader for assigned Quality System(s) Manages day-to-day proactive and effective quality processes and systems within the External Quality (EQ) Processes & Operations to support external manufacturing globally. Ensures EQ is in full compliance with regulatory, industry and Johnson & Johnson Supply Chain requirements and standards. Resolves planned and unplanned issues regarding compliance, quality systems and training....

A Supplier Quality Engineer collaborates with a diverse network of suppliers to resolve quality challenges affecting production. This role involves working closely with the production team to promptly address issues and drive improvements in component quality. The engineer will play a key role in establishing quality standards for suppliers, enhancing quality system programs, and partnering with cross-functional teams to execute qualification projects. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and...

Quality Assurance Senior Manager What you will do This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality. Key Responsibilities include Ensure appropriate quality oversight of suppliers in line with global regulations, define quality requirements for suppliers and monitor performance Quality liaison between Amgen and the supplier Negotiator and owner of quality agreements Prepare external site for inspections including development of inspection playbooks....

Lead global regulatory strategy and execution for our innovative biologics/combination product portfolio. As Sr. Director of Regulatory Strategy, you will shape and drive regulatory pathways from preclinical through commercialization and lifecycle management. This key leadership role combines strategic oversight of registration requirements, regulatory submissions, and health authority interactions across markets. The ideal candidate brings deep expertise in global biologics regulations, with demonstrated success in navigating complex regulatory landscapes for combination products. Join our dynamic team to advance breakthrough therapies while ensuring regulatory excellence and compliance across all stages of drug development. The ideal candidate will live in the San Diego...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson is currently seeking a Facilities Management Compliance Lead to join our team. The role will be located in Wilson , North Carolina . As the FM Compliance Lead you will be responsible for the compliance and...

Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs. What You’ll Work On Prepares robust regulatory applications to achieve departmental and organizational objectives. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates. Compile,...

The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including companion diagnostics (CDx), as they pertain to the Novartis innovative medicines portfolio, including its marketed products. The RDM works with oversight of senior members of the Regulatory Affairs Precision Diagnostics Team including the TA and Diagnostics Lead on strategies and submissions including companion diagnostics, in close collaboration with internal RA Disease Unit associates, associates of Digital, Data and Clinical Innovation (DDCI) at Novartis as well as Partner Companies that develop diagnostics and ensures adherence to regulatory requirements. The RDM will...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Quality Compliance Manager What you will do Let’s do this! Let’s change the world! We are hiring a Quality Compliance Manager, which will operate within the General Medicine & Obesity Quality Therapeutic Area. In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals). Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting...

We are looking for the best talent for a Senior Quality Engineer to be located in Cornelia, GA with occasional travel to Athens, GA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at You will be responsible for Determine quality standards and ensure compliance with industry regulations. Develop and implement quality control processes to ensure flawless production. Collaborate with diverse teams to identify areas for improvement and implement effective solutions. Conduct thorough product...

Johnson & Johnson is hiring for a Principal Quality Systems Specialist – Shockwave Medica l to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at...

The Senior Manager Distribution Quality Operations p rovides oversight and support for quality compliance of BMS products at 3PL distribution centers (DCs) and during transportation between facilities. Ensures that BMS quality compliance expectations are met and maintains inspection readiness. Collaborates to develop quality strategies for storage, transportation, and distribution of products. Key Responsibilities Serves as primary DQ USPR contact and provides quality oversight/support for the Manchester, PA USDC and BMS Puerto Rico’s 3PL DC. Reviews and approves change control documents related to storage, transportation, and distribution of products. Supports product launch preparation and activities. Conducts pre-approval assessments and other regulatory...

A Day in the Life Medtronic is currently searching for a Principal Quality Engineer to join the New Product Development team at the Lafayette, CO facility. You’ll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities. Key Responsibilities Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services. Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems. Experience with PCBA suppliers and validation of PCBA test...

Medtronic is a world leader in providing health care products that restore health and extend life. The Medtronic Diabetes R&D team contributes directly to this mission; we deliver software and firmware for Medtronic’s pump and continuous glucose monitoring devices. Our business is growing significantly as the market demands reliable medical devices which look and feel more like consumer devices. We are looking for an Associate Quality Systems Specialist who can help us continue to make devices more robust and reliable for our patients. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention...

We are looking for a skilled and detail-oriented Quality Tech III. This role is a critical part of our operations, responsible for environmental monitoring and testing/labs. Responsibilities may include the following and other duties may be assigned. Reviews sterilization and microbiology test records for accuracy and completion as a part of sterile release process Performs microbiological testing in laboratory and controlled environments Reviews and approves test reports Coordinates shipping of test samples to contract laboratories Maintains inventory of laboratory supplies Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to...

About Synchron Synchron is a neurotechnology company with a mission to deliver the first commercially scalable brain-computer interface (BCI) for millions of people with paralysis to reconnect with the world. Our minimally invasive BCI system is designed to enable users to control digital devices directly through thought, restoring access and control over the digital world. Our team is working at the intersection of healthcare and technology to translate breakthrough research into real-world care. Join us in shaping a more connected and accessible future. As a Quality Assurance Engineer in our newly formed division in San Diego, CA, you will...

The Senior Regulatory Program Manager will manage implementation regulatory activities of Robotics Surgical Technologies (RST) portfolio. The mission of Global Regulatory Affairs is to influence the regulatory environment, develop innovative strategies for regulatory approval and post-introduction requirements, and anticipate and respond to changing requirements in order to benefit the patients we serve. Location Strong preference to have a candidate work from Lafayette, CO, Boston, MA, North Haven, CT, or Mounds View , MN. Will consider candidates to work from another MDT facility in the U.S. or work remotely within the U.S. Travel 25% Responsibilities may include the following and other...

Provides Regulatory Strategy support for the preparation of and coordination of document packages for regulatory submissions. Conducts review of regulatory documents. Maintains various regulatory databases and document tracking systems. Under direct supervision, may act as Regulatory Strategy department contact for various internal projects or program activities. _ Your Contributions (include, but are not limited to) Under direct supervision, assist with preparation ofsubmissions to regulatory authorities (e.g. clinical trial applications, IND/IND supporting documents and maintenance submissions, annual reports, expedited safety reports) Conducts review of clinical regulatory documents. Performs quality checks of submission documentation and publishing output Updates and maintains logs, databases...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Senior Associate – Specialist, Global Regulatory Affairs CMC role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows With supervision , support the execution of regulatory CMC investigational , registration and post- approval strategies...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi, an integrated global healthcare leader , discovers, develops and distributes therapeutic solutions focused on patients' needs . Sanofi has core strengths in the field of healthcare with seven growth platforms diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, and animal health . The Compliance Specialist will be...

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. This position supports the execution of routine and non-routine testing in the QC Virology PCU to ensure the safety, potency, and purity of biological products in compliance with Federal Regulations, cGMP, and Sanofi policies and procedures. This position requires the individual to compliantly perform viral assays as scheduled, analyze results,...

Senior Specialist Quality Control – Technical Resources What you will do Let’s do this. Let’s change the world! In this vital role you will be the technical specialist for Amgen Manufacturing Limited, QC Operations. You will serve as a key technical leader supporting the Quality Control (QC) laboratories. You will be responsible for addressing complex technical challenges with cross-functional, multi-site, and external impact. Collaborating across Quality Control, Quality Assurance, Manufacturing, Engineering, and Process Development, your work will be critical in ensuring the robustness and reliability of lab operations. Specific responsibilities include but are not limited to Technical Expertise & Troubleshooting...

Director- Site Quality Head The Opportunity Abbott Diabetes Care has an opportunity for a Director - Site Quality Head. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies. What You’ll Work On Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially...

Job Title Software Quality Engineer II Our location in Sylmar, CA currently has an opportunity for an Software Quality Engineer . This is a fully onsite role . This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. WHAT YOU’LL DO Provide guidance and training to the...

This position works out of our Minnetonka, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a passionate Manager in Quality Engineering to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products...

Purpose The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks...

We are searching for the best talent for a Manager, Health Care Compliance to be based in Santa Clara, CA; New Brunswick, NJ; Raritan, NJ; West Chester, PA; Irvine, CA; or Danvers, MA. Purpose The Healthcare Compliance Manager will support Shockwave Medical, and play a key role in ensuring the Company meets statutory and regulatory requirements relating the health care fraud and abuse; as well as advertising and promotion laws governing commercial and scientific activities. This role will also support Shockwave’s health care compliance integration activities. You will be responsible for Partner with business and functional stakeholders and provide compliance...

Senior Manager/Associate Director, Regulatory Medical Writing X-TA At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at...

Johnson & Johnson is currently recruiting for a CAR-T Specialist 3, Quality Assurance Microbiology. This position will be located in Raritan, NJ. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at [CAR-T is...

About Vision Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime....

As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions. The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions. This is a broad scoped position with strong opportunity for growth and career development based on performance. What You’ll Work...

Position We are seeking an experienced Senior Manager to Associate Director, Regulatory Affairs, to manage our regulatory clinical trial applications (CTAs) and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to develop ex-US CTAs, and manage the maintenance of applications submitted to Competent Authorities (CAs) in support of study initiation. This role is a member of the program teams within the function of Regulatory Affairs.This role will require a minimum of 3 days a week of onsite presence (or...

About the role As Senior Validation Engineer, you will support the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement. You will report to Head of Engineering Services. This is an on-site position, and you will be required to work all five days from the office. How you will contribute Be a Validation Engineering representative and technical subject matter expert (SME)...

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s...

Provides leadership & strategy for a group of IT professionals supporting a major organizational unit responsible for the definition, development, implementation, operation and support of computer-based systems and related processes and tools which provide information for reporting, operations, and decision making for the Quality Non-Complaints, LMS (Learning Management), DMS (Document Management), and Global Engineering Systems (GES) within the Quality-Regulatory-Engineering Services BSS Organization. What You'll Work On Creates and manages Corporate Quality Non-Complaints, LMS, DMS & GES Strategies and Architectural Framework in partnership with Divisional BRM’s Aligns department priorities appropriately, determines critical success factors, evaluates and pursues initiatives, investments and opportunities...

As Senior Analyst, Data Quality, you will join our Commercial Data Management team and become a key contributor in building scalable quality control processes and partnering closely with cross-functional teams to ensure our data is trusted, accurate, and business-ready. This is an exciting opportunity for a detail-oriented, analytical thinker who enjoys tackling complex data challenges, working collaboratively across teams, and utilizing cloud data technologies to make a significant impact in a pivotal position. Your responsibilities will include the following activities _ Your Contributions (include, but are not limited to) Execute recurring quality control checks on commercial datasets including sources such...

Careers That Change Lives In this exciting role as a Sr Quality Engineer you will Witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life. Representative and/or Lead for the New Product Introduction ( NPI ) Quality team on the NPI Core Team on small to medium size project s . Compliance oversight over the medical device NPI activities in accordance with the applicable Standard Operating Procedures (SOP's) and External Standards as part of the NPI process. Contribute and lead activities during the following activities Risk analysis, including product risk a ssessment...

Responsibilities may include the following and other duties may be assigned. Performs analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. Performs a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Reviews production records for conformance to procedures. Conducts...

Careers that Change Lives A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people . Help us engineer the extraordinary! Bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description. We...

The Quality Systems Senior Specialist is responsible for providing quality assurance support for some or all of the following manufacturing processes pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations. This role is part of the External Quality Assurance (EQA) team responsible for product quality across a portfolio of topical skincare products that include Natural...

This is an exciting opportunity to lead the Biostatistics efforts supporting Natera’s product portfolio of cutting-edge cell-free DNA screening tests. As Lead Biostatistician, you will leverage your medical device/assay development background along with your experience in applied statistics to oversee the design, analysis, and reporting of validation experiments to support our Women’s Health and Organ Health portfolio. The ideal candidate will possess strong communication skills and a deep understanding of biostatistics in analytical validation. PRIMARY RESPONSIBILITIES Study Design and Analysis Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of Women’s Health and Organ Health product...

The Senior Design Quality – Electronic Engineer position, is one of development, improvement and innovation. If you pride yourself on your problem-solving skills and a meticulous attention to detail this may be the role for you. You will be tasked to provide quality engineering support in the design and development of electronic medical device products. Facilitate the application of Design Controls, Risk Management and Change Control processes in the evaluation and implementation of changes to released products. Responsibilities may include the following and other duties may be assigned. Previous experience in Electronic PCB design and development. Preferably with a formal...

Role Senior Design Quality Engineer The Design Quality Engineer position is one of development, improvement, and innovation, through cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality engineering support in design and development of medical device products across the Acute Care and Monitoring [ACM] portfolio of products. Facilitate the application of design controls, Risk Management and Change Control processes in the evaluation and release of product changes. As our Senior Design Quality engineer, your Key Accountabilities...

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Eli Lilly and Company seeks a Regulatory Affairs Director (R7-R8) to...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Deviation Mentor is a key member of the Quality Assurance...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Eli Lilly and Company seeks an Advisor, Global Quality Labs (R5)...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. KEY RESPONSIBILITIES The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions,...

Key Responsibilities Lead strategy and execution of complex sterile product qualification activities. Expertise in contamination control, cleaning validation and isolator systems. Adopt best practices for continuous qualification of sterile production facilities. Provides relevant CMC support for sterile products pre- and post-approval filings. Interface with Senior Leadership Team to provide a unified set of goals and objectives for the Validation team. Assist with onboarding of new technologies and provide oversight for new qualification programs. Work with Quality to adopt an effective quality management system and achieve the quality objectives. Provide leadership for Validation team and ensure growth and development of staff...

GCP Quality Compliance Manager What you will do Let’s do this! Let’s change the world! In this vital role you will provide critical support to the Process Quality function by assisting in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight. Accountabilities Assist in maintaining and improving the QMS by helping to track, document, and implement quality initiatives, ensuring that procedures and processes meet regulatory requirements. Contribute to the collection, analysis, and reporting of quality metrics (KPIs, KQIs), helping to identify trends, risks, and areas for continuous improvement. Provide hands-on support to...

We anticipate the application window for this opening will close on - 20 Oct 2025 Position Sr. Supplier Quality Engineer for Medtronic, Inc. located in Minneapolis, MN. Responsible for communicating technical objectives between Medtronic and suppliers. Coordinate with cross-functional groups in supplier selection process. Developing and maintaining incoming inspection procedures, ensuring inspector trainings and qualifying parts for SOQ program. Responsible for Supplier Change process between Medtronic and Suppliers to evaluate and implement changes at Supplier. Responsible for Supplier and Medtronic CAPA (Corrective and Preventive Action) Supplier related Product and Process NCMR (Nonconforming Material Report) by working with the supplier...

At Medtronic, we’re on a mission to alleviate pain, restore health, and extend life. As a Senior Quality Systems Specialist , you will play a critical role in ensuring compliance with global regulatory requirements while helping to continuously improve our quality system to support innovation and patient safety. This is your opportunity to apply your quality systems expertise in a collaborative environment where your work truly matters. As a Senior Quality Systems Specialist, you will Lead and support Quality System processes , such as CAPA (Corrective and Preventive Action), Internal Audits, Management Review, and Document Control. Serve as a subject...

We are searching for the best talent for a Senior Manager, Health Care Compliance Officer to be based in Horsham, PA. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Purpose The Senior Manager, Health Care Compliance Officer will be responsible for collaborating with Commercial and Medical Affairs on activities and...

Job Summary Auris Health, a member of Johnson & Johnson's Family of Companies, is recruiting for Head of Quality and Compliance (Q&C) Leader for our Monarch platform. This role will directly report to Global VP of Q&C Robotics and Digital Surgery and will be in Santa Clara, California. This role is an end-to-end role with responsibilities including Design & Development, Manufacturing/Operations, Quality & Compliance and Post Market Surveillance. As a leader, you will drive exceptional Quality and Compliance including focus on customer safety and product design, and manufacturability and reliability throughout the Product Development, Operations, Distribution, and Commercial processes. The...

The Opportunity Abbott’s Digital Solutions organization, part of the Medical Devices group, partners with our Diabetes, Cardiovascular, and Neuromodulation businesses to develop and commercialize digital technologies that expand access to care, optimize medical procedures, and improve chronic disease management. Together with Abbott’s life-changing medical devices, Digital Solutions leverages technologies such as AI and data interoperability to enable people to live life to the fullest. We are seeking a Director, Quality Assurance to join our team and establish the QA function within Digital Solutions for a diverse and growing portfolio of digital health products, including software as a medical device (SaMD),...

Onsite- 100% At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working onsite 5 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this exciting role as a Supplier Quality Engineering (SQE) Manager , you will be responsible for ensuring the quality and compliance of electronic components, indirect materials, and services procured at our Medtronic Tempe Campus (MTC) for the design and manufacture of...

The Senior Auditor, Global Compliance Audit, has the primary responsibility of conducting global sales and marketing compliance audits for all of Abbott’s global operating divisions and Affiliates. Compliance audits provide assurance on the effectiveness of the key elements of Abbott’s Ethics & Compliance Program. The audit scope areas covered include, but are not limited to, the following activities undertaken by the Commercial businesses within the Corporation Meals, Travel and Entertainment Expenses Professional Service Arrangements Training & Education Support Charitable Contributions Commercial Transactions Research Funding and Scientific Activities /Publications No-Charge Products Promotional Practices Ethics & Compliance Program Third-party Activities Transparency Reporting...

Job Title Quality Manager Our location in Sylmar, CA currently has an opportunity for a Quality Manager . This is a fully onsite role . The Quality Manager is responsible for implementing and maintaining an effective Quality System. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. WHAT YOU’LL DO Responsible for implementing and maintaining an effective Quality System as it relates to Post Market and Management Responsibility Independently lead groups and projects to resolve complex issues. analyze complex problems...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. As a Senior Quality Compliance Manager, the individual will play a crucial role within Abbott’s Heart Failure organization with primary focus to maintain overall Quality Management System compliance to internal policies, applicable standards and external regulatory requirements. What You’ll Work On The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications...

GeneDx (Nasdaq WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com . Summary The Quality Systems Specialist II is responsible for supporting, maintaining, and improving the Quality Management System (QMS) at GeneDx. This role...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Company Overview At Lilly, we serve an extraordinary purpose. We make...

Quality Assurance Senior Manager What you will do Let’s do this! Let’s change the world! In the rapidly evolving landscape of clinical trials, ensuring the quality and compliance of innovative technologies is paramount. This role reports to the Executive Director, Precision Medicine/Diagnostics and R&D Supplier Quality, and is dedicated to supporting the implementation of a comprehensive and proactive Quality Assurance (QA) strategy for diagnostic or health technology products used in Clinical Trials, including third-party collaborations and oversight. The individual in this role is crucial in managing and overseeing programs and projects related to R&D supplier/service provider quality, diagnostics, imaging, digital...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You will lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Medtronic’s eDiscovery program is a key program in the broader strategy of Global Information Lifecycle Management, Discovery Management, and overall good data stewardship. This position offers the opportunity to manage eDiscovery for a wide variety of litigation and legal matters. The eDiscovery Specialist reports to the Sr Program Manager of Global Information and Discovery Management. This is an individual contributor role. This role...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. How you will contribute As our Associate Director, Global Regulatory Affairs...

AbbVie’s Global Internal Audit function plays a critical role in protecting and enhancing the organization’s value through risk-based assurance and advisory services to internal stakeholders, senior management, and our Audit Committee of the Board. Internal Audit strives to be a critical function to evaluate company, industry and emerging risks, effectively partnering with the business, and consistently recruit and develop key talent. Our goals are carried-out through the talent of the audit team, while leveraging analytical and audit tools, supported by a dynamic and collaborative team culture. The scope of compliance audits may include, but is not limited to, the following...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Manager, Quality Engineer is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility...

About the Role This position will drive computer system validation activities for the Summit site Manufacturing Execution Systems (MES) supporting the Summit, NJ Cell Therapy manufacturing site. This role is ideal for someone with a strong IT/Computer Science foundation and 5 years or more of hands-on experience in the pharma/biotech industry. You’ll partner with other cross-functional teams such as QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions and support. Key Responsibilities Lead end-to-end validation activities including test preparation, authoring of IQ/System/UAT scripts, Dry Run, test data setup, environment readiness, test execution facilitation,...

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Associate II, Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but...

Associate Director, Clinical Regulatory Writing Location Boston, MA Introduction to role Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZeneca’s core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals. Accountabilities As a Clinical Regulatory Writing Associate Director, you will...

Sr. Supplier Quality Engineer Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Temecula, CA , currently has an opportunity for a Senior Quality Engineer . This role will serve as liaison between internal Abbott third party manufacturers and Abbott Vascular. Ensures effective implementation of quality and compliance requirements between multiple quality systems and sites. THIS IS AN ON-SITE DAILY ROLE. WHAT YOU'LL DO Position Responsibilities Work...

About the role As a Supervisor, Quality Control, you will have a staff performing many biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. You will be responsible for results regarding product quality and conformance to regulations and quality policies. In some instances, you will be responsible for a functional area and may not have team members. This position works 600pm- 230am Monday-Friday....

We anticipate the application window for this opening will close on - 14 Oct 2025 Position Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Fridley, MN. Responsible for New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the development and maintenance of high-quality, reliable, and safe medical devices that meet or exceed regulatory standards and customer expectations. Coordinate complaint investigations for Medtronic’s returned implantable devices. Accept and handle returned implantable devices, cleaning and sterilization process. Coordinate test results, clinical data, DHR (Device History Records) and product performance data....

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Senior Manager, Global Regulatory Project Management and Strategic Planning within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)...

Your skills could be critical in helping our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and disease-related materials for assigned products. As the product expert, this individual helps to develop and implement regulatory strategies related to promotional and advertising campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB). We are an innovative global healthcare company with one...

Careers that Change Lives Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. Agility and responsiveness are critical to our success with remote monitoring, wearables, robotics, AR/VR, telemedicine, and more. Experience what it’s like to work at a company with an exciting product pipeline of patented inventions driving innovation in the healthcare space. The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Associate Director - Import Trade Compliance Responsibility Statement Lead the operations...

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. What You Will Achieve In this role, you will Perform batch record review and final batch disposition for clinical and commercial materials to ensure high quality products are released in a timely manner Effectively review/approve GMP documents to ensure quality attributes are met. Participate in...

This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. We are seeking an experienced, high caliber Senior Supplier Development Quality Engineer to be responsible to act as the site interface to suppliers. What You’ll Work On Drives the development, maintenance and improvement of quality of components sourced from outside suppliers. Reviews new design specifications and proposes changes to existing specifications to support component quality and manufacturability. Develops...

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our Diabetes division currently has an opportunity for a Software Data Validation Engineer II. What You'll Do Investigate and report unexpected events, issues or software bugs through the data output from production telemetry. Investigation may include marco quality issues spanning multiple months of data...