GSK
Senior Device Quality Engineer Associate Director
USA - Pennsylvania - Upper Providence · Hybrid (Remote & On-site) · Director · Full-time · Posted Oct 12, 2026
- Experience
- Minimum 5 years’ experience in medical device quality engineering or regulated manufacturing.
- Education
- Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or related field.
About the job
Leads quality engineering for medical device products in combination products, ensuring safety, compliance, and quality from design through manufacturing and post-market monitoring.
What you'll do
- Oversee device design controls, risk management, design transfer, and manufacturing scale-up.
- Lead quality event investigations and corrective actions; review and approve quality documents.
- Support post-market surveillance, continuous improvement, audits, and inspections with cross-functional teams.
What they ask for
- Bachelor’s degree in biomedical, mechanical, electrical, quality engineering, or a related field.
- Working knowledge of medical-device quality systems and standards, such as ISO 13485 and FDA 21 CFR part 820.
- Hands-on experience with root cause analysis and CAPA execution.
- Ability to review technical drawings, specifications, and test data; strong communication and cross-functional collaboration skills.
Nice to have
- Advanced degree in engineering or a quality-related discipline.
- Experience with ISO 14971, supplier quality and audits, statistical tools/DOE/process capability, or regulatory submissions and inspections.
Tools
ISO 13485, FDA 21 CFR part 820, ISO 14971, EU MDR, CAPA, DOE
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