Senior Medical Device Quality Engineer

GSK; Collegeville (PA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Meaningful impact

Career development opportunities

Inclusive environment

Job summary

GSK in the United States is seeking a Quality Engineer to lead quality engineering activities for medical device products, collaborating with design, manufacturing and regulatory teams to ensure safety, reliability and compliance.

You will grow by influencing product quality and patient outcomes while applying ISO 13485, FDA 21 CFR 820, and ISO 14971, with opportunities across diverse, multidisciplinary teams in a hybrid work model in the Collegeville area.

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or related field.
• Minimum 5 years’ experience in medical device quality engineering or regulated manufacturing.
• Working knowledge of quality systems and standards relevant to medical devices, such as ISO 13485 and FDA 21 CFR part 820.
• Hands‑on experience with root cause analysis and CAPA execution.
• Ability to read and review technical drawings, specifications, and test data. Strong communication skills and experience working cross‑functionally with engineering and operations teams.

Responsibilities

• Provide quality oversight of device design control activities for new combination products from clinical design planning through first commercial product launch.
• Support design transfer and manufacturing scale-up to ensure robust processes and device conformity.
• Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.
• Provide quality oversight of risk management files (ISO 14971) and Design and Development Files (ISO 13485).
• Support and contribute to device development process and QMS improvements.
• Lead investigations into quality events, using root cause analysis and corrective action plans.
• Review and approve quality documents, including protocols, test reports, and risk management files.
• Monitor product performance through post-market surveillance and drive continuous improvement.
• Collaborate with regulatory, supply chain, and manufacturing partners to support audits and inspections.

Skills

Root Cause Analysis

CAPA

Quality Systems

Cross-functional Collaboration

Reading Technical Drawings

Data Analysis

Communication Skills

Education

Bachelor's degree in biomedical, mechanical, electrical engineering, quality engineering, or related field

Job description

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bring our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bring our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary:

You will lead quality engineering activities for medical device products. You will work across design, manufacturing, and regulatory teams to ensure product safety, reliability, and compliance. We value clear communicators who solve problems with data and practical judgment. You will grow your career by influencing product quality and patient outcomes while working with talented, multidisciplinary teams aligned to our mission of uniting science, technology and talent to get ahead of disease together.

Key Responsibilities:

• Provide quality oversight of device design control activities for new combination products from clinical design planning through first commercial product launch.
• Support design transfer and manufacturing scale-up to ensure robust processes and device conformity.
• Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.
• Provide quality oversight of risk management files (ISO 14971) and Design and Development Files (ISO 13485).
• Support and contribute to device development process and QMS improvements.
• Lead investigations into quality events, using root cause analysis and corrective action plans.
• Review and approve quality documents, including protocols, test reports, and risk management files.
• Monitor product performance through post-market surveillance and drive continuous improvement.
• Collaborate with regulatory, supply chain, and manufacturing partners to support audits and inspections.

Basic Qualifications:

• Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or related field.
• Minimum 5 years’ experience in medical device quality engineering or regulated manufacturing.
• Working knowledge of quality systems and standards relevant to medical devices, such as ISO 13485 and FDA 21 CFR part 820.
• Hands‑on experience with root cause analysis and CAPA (corrective and preventive action) execution.
• Ability to read and review technical drawings, specifications, and test data. Strong communication skills and experience working cross‑functionally with engineering and operations teams.

Preferred Qualifications:

• Advanced degree in engineering or quality‑related discipline.
• Experience with risk management standards such as ISO 14971.
• Familiarity with supplier quality management and supplier audits.
• Proficiency with statistical tools, design of experiments (DOE), and process capability analysis.
• Experience supporting regulatory submissions or inspections.

Work Arrangement:

• This role is hybrid, with regular onsite collaboration in the United States and some remote flexibility. Travel may be required for supplier visits, audits, or cross‑site collaboration.

What we offer you:

You will join a team focused on meaningful, measurable impact for people who need better health outcomes. You will receive opportunities to develop technical skills, lead important projects, and grow your career. We support an inclusive environment where everyone can contribute and learn.

Skills:

Data Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Project Management, Quality Assurance (QA), Quality Management Systems (QMS), Risk Awareness, Technical Writing

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/