Senior Device Quality Engineer

GlaxoSmithKline; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

GlaxoSmithKline seeks a seasoned quality/regulatory professional to oversee medical device compliance within combination products across the product lifecycle, from design to post-market surveillance.

You will lead risk management, CAPA investigations, investigations, and QA systems, collaborating with engineering and operations to ensure readiness for regulatory inspections. On-site with hybrid flexibility based on business needs.

Qualifications

• Bachelor's degree in a scientific, engineering, or technical discipline with medical device expertise or equivalent.
• 8+ years in pharmaceutical/biopharmaceutical or related industry with device manufacturing and quality oversight.
• Hands-on investigations, root-cause analysis, CAPA management, and problem-solving experience.
• Working knowledge of QMS and cGMP regulations.

Responsibilities

• Ensure FDA/ISO/EU MDR and GSK compliance for devices in combination products.
• Maintain and improve risk management files (ISO 14971) and DDF (ISO 13485).
• Review/approve technical docs and quality plans; support product development.
• Lead investigations for nonconformances, deviations, and CAPA activities.
• Monitor site KPIs, identify risks, and develop mitigation for patient safety and quality.
• Lead site readiness for regulatory inspections and audits; SME for device quality.
• Collaborate with suppliers and internal teams to resolve component quality issues.
• Support device lifecycle management, design changes, and post-market monitoring.

Skills

QMS knowledge

cGMP

CAPA & investigations

Root cause analysis

Regulatory knowledge (US)

Design & DDF knowledge

Quality systems experience

Education

Bachelor's degree in science/engineering

Job description

Position Summary

This position ensures products meet safety, regulatory, and quality standards throughout the product lifecycle, from design and development to post-market surveillance for medical devices within combination products. Responsibilities include risk management, participation in root cause analyses, process validation, and maintaining Design and Development Files (DDF) related to medical devices.

Responsibilities

• Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.
• Maintain and improve risk management files (ISO 14971) and Design and Development File (ISO 13485).
• Review/Approve technical documentation, quality plans, and support new product development and introduction.
• Support process improvements, validations and ensure production complies with required specifications for medical device manufacturing (filling, assembly and packaging) within combination products.
• Lead investigations for device-related nonconformances, deviations, and complaints.
• Monitor and trend site KPIs for device processes, identify risks, and support development of mitigation strategies focused on patient safety and quality.
• Lead site inspection readiness for device related areas and act as the subject matter expert for regulatory inspections and audits.
• Partner with suppliers and internal teams to resolve component quality issues and support supplier quality management.
• Support device lifecycle management activities, including continuous improvement, design changes, post-market quality monitoring, and the maintenance and compliance of the Design and Development File (DDF).
• Act as site Subject Matter Expert (SME) for device quality processes, providing guidance to operations, engineering, and quality teams.

Why You?

We seek clear communicators who care about quality and patient safety. You will join a collaborative team that values learning and personal growth. The role is on-site with hybrid flexibility where local site needs allow. You will have opportunities to lead projects, broaden technical skills, and influence quality practices across functions.

Basic Qualification

• Bachelor's degree (BA/BS) in a scientific, engineering, or technical discipline, with demonstrated medical device expertise or equivalent combination of education and experience.
• Minimum of 8+ years of relevant experience in the pharmaceutical, biopharmaceutical, or related industry, including direct experience in manufacturing and quality oversight of medical devices.
• Demonstrated hands-on experience conducting investigations, performing root cause analysis, and managing Corrective and Preventive Action (CAPA) processes.
• Working knowledge of Quality Management Systems (QMS) and current Good Manufacturing Practice (cGMP) regulations.

Preferred Qualification

• Communication & Collaboration: Strong written and verbal communication skills, with the ability to effectively collaborate and influence across cross-functional teams.
• Regulatory & Audit Support: Experience supporting audits and regulatory inspections, including preparation, coordination, and response management.
• Device Assembly Expertise: Preferred experience in the management and oversight of pre-filled syringe and autoinjector assembly processes.
• Design & Development Knowledge: Working knowledge of design controls, risk management, and Design and Development File (DDF)/Design History File (DHF) requirements.
• Regulatory Knowledge: Understanding of global regulations, regulatory expectations, inspection practices, emerging technologies, and industry standards related to medical devices and combination products.
• Quality Systems Experience: Experience with change control, process validation, investigations, root cause analysis, and CAPA management for quality and manufacturing issues.
• Advanced Education: Advanced degree in Engineering, Biomedical Engineering, or a related discipline preferred.
• Risk Management & Human Factors: Experience with human factors engineering, design controls, and device risk management (e.g., ISO 14971).
• Regulatory Familiarity (U.S.): Familiarity with device-specific standards and regulatory requirements in the United States.
• Supplier Quality: Background in supplier quality management for device components.
• Validation & Testing: Practical experience with validation, verification, and product release testing.
• Analytical Tools: Experience utilizing quality and problem-solving tools such as FMEA, 8D methodology, and statistical analysis software.

Additional Info

• Work Schedule: This is an onsite position operating Monday through Friday, with the potential to transition to a hybrid schedule (3-4 days onsite per week) based on business needs.

What we offer

You will join a purpose-driven workplace that supports career development and well-being. We provide training, mentorship, and opportunities to grow your technical and leadership skills. We are committed to creating an inclusive environment where everyone can contribute and belong.

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/