Senior Medical Device Quality Engineer

Socket.dev; Upper Providence (Delaware County); Hybrid; USD 110,000 - 150,000; Full time

Job summary

GSK is seeking a Quality Engineer to lead quality oversight of medical device design controls for combination products in the United States. You will collaborate with design, manufacturing and regulatory teams to drive product quality and patient outcomes.

The role requires experience in ISO 13485, FDA 21 CFR 820, ISO 14971 risk management, and CAPA investigations, with hands-on ability to review technical documentation and support inspections; this hybrid US-based position offers

Qualifications

• Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or equivalent.
• Minimum 5 years’ experience in pharmaceutical/biopharmaceutical industries with medical devices or combination products.
• Experience with investigations, RCA, CAPA, change controls, and process validation.
• Knowledge of ISO 13485, FDA 21 CFR 820, and risk management activities.
• Experience reading technical drawings, specs, and test data.

Responsibilities

• Provide quality oversight of device design control activities for new combination products through launch.
• Review and approve technical documentation and support new product development and QMS improvements.
• Lead investigations for device nonconformances, deviations and complaints.
• Ensure customer feedback informs development of new combination products and device platform consistency.
• Lead R&D inspection readiness and act as SME for regulatory inspections and audits.

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

Education

Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or equivalent

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 in 2024 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:

This position ensures products meet safety, regulatory, and quality standards from design and development to first product launch for medical devices within combination products. Responsibilities include quality oversight of device design control activities, risk management, root cause analyses, and Design and Development File (DDF). You will lead quality engineering activities for medical device products in the United States. 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. 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). Review/Approve technical documentation, quality plans, and support new product development and introduction. Support and contribute to device development process and QMS improvements. Lead investigations for device nonconformances, deviations, and complaints.


• Ensure customer feedback is considered as part of the development of new combination products and consistency across products using the same device platform ensuring patient safety and quality.


• Lead R&D inspection readiness for device related areas and act as the Subject Matter Expert (SME) for regulatory inspections and audits.


• Partner with suppliers and internal teams to resolve component quality issues and support supplier quality management.

Basic Qualifications:

• Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or equivalent level of knowledge.


• Minimum 5 years’ experience in pharmaceutical and/or biopharmaceutical or related industries, with experience in manufacturing and quality oversight of medical devices or combination products, with preferred experience in management of pre-filled syringe and autoinjector assembly.


• Experience conducting investigations, root cause analysis, CAPA management for quality and manufacturing issues, change controls, process validation. Experience participating in risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms is an asset.


• Experience with design controls, risk management, and Design and Development Files (DDF)/ Design History File (DHF) requirements. Knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, new technologies, industry standards and registered risks pertaining to medical devices.


• 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.

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.


• Experience with medical device software or combination product quality.

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

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.

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.

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]