Senior Device Quality Engineer
GSK
August 18, 2026
Remote friendly (Zebulon, NC)
United States
Operations
Position Summary
- Ensures products meet safety, regulatory, and quality standards throughout the product lifecycle for medical devices within combination products, including design/development through post-market surveillance.
Responsibilities
- Ensure compliance with FDA, ISO, EU MDR, global, and GSK requirements for medical devices in combination products.
- Maintain and improve risk management files (ISO 14971) and Design and Development File (ISO 13485).
- Review/approve technical documentation and quality plans; support new product development and introduction.
- Support process improvements and validations; ensure production complies with required specifications for medical device manufacturing (filling, assembly, packaging).
- Lead investigations for device-related nonconformances, deviations, and complaints.
- Monitor/trend site KPIs for device processes; identify risks and develop patient-safety/quality mitigation strategies.
- Lead inspection readiness for device-related areas; serve as SME for regulatory inspections and audits.
- Partner with suppliers and internal teams to resolve component quality issues; support supplier quality management.
- Support device lifecycle management (continuous improvement, design changes, post-market quality monitoring) and maintain DDF compliance.
- Act as site SME for device quality processes.
Basic Qualifications
- Bachelor’s degree (BA/BS) in scientific, engineering, or technical discipline with demonstrated medical device expertise (or equivalent).
- 8+ years relevant experience in pharma/biopharma/related industry with direct medical device manufacturing and quality oversight.
- Hands-on experience with investigations, root cause analysis, and CAPA.
- Working knowledge of QMS and current cGMP.
Preferred Qualifications
- Audit/regulatory inspection support; cross-functional communication.
- Experience with pre-filled syringe/autoinjector assembly oversight.
- Knowledge of design controls, risk management, and DDF/DHF.
- Global regulatory knowledge; change control, validation, investigations, and CAPA.
- Advanced degree (Engineering/Biomedical Engineering preferred).
- Human factors and device risk management (e.g., ISO 14971); U.S. regulatory familiarity.
- Supplier quality, validation/verification/release testing, and tools (FMEA, 8D, statistical software).
Work Schedule
- Onsite Mon–Fri; potential hybrid (3–4 days onsite/week) based on business needs.
How to Apply
- Submit resume and a brief cover note outlining relevant experience and interest.
- Ensures products meet safety, regulatory, and quality standards throughout the product lifecycle for medical devices within combination products, including design/development through post-market surveillance.
Responsibilities
- Ensure compliance with FDA, ISO, EU MDR, global, and GSK requirements for medical devices in combination products.
- Maintain and improve risk management files (ISO 14971) and Design and Development File (ISO 13485).
- Review/approve technical documentation and quality plans; support new product development and introduction.
- Support process improvements and validations; ensure production complies with required specifications for medical device manufacturing (filling, assembly, packaging).
- Lead investigations for device-related nonconformances, deviations, and complaints.
- Monitor/trend site KPIs for device processes; identify risks and develop patient-safety/quality mitigation strategies.
- Lead inspection readiness for device-related areas; serve as SME for regulatory inspections and audits.
- Partner with suppliers and internal teams to resolve component quality issues; support supplier quality management.
- Support device lifecycle management (continuous improvement, design changes, post-market quality monitoring) and maintain DDF compliance.
- Act as site SME for device quality processes.
Basic Qualifications
- Bachelor’s degree (BA/BS) in scientific, engineering, or technical discipline with demonstrated medical device expertise (or equivalent).
- 8+ years relevant experience in pharma/biopharma/related industry with direct medical device manufacturing and quality oversight.
- Hands-on experience with investigations, root cause analysis, and CAPA.
- Working knowledge of QMS and current cGMP.
Preferred Qualifications
- Audit/regulatory inspection support; cross-functional communication.
- Experience with pre-filled syringe/autoinjector assembly oversight.
- Knowledge of design controls, risk management, and DDF/DHF.
- Global regulatory knowledge; change control, validation, investigations, and CAPA.
- Advanced degree (Engineering/Biomedical Engineering preferred).
- Human factors and device risk management (e.g., ISO 14971); U.S. regulatory familiarity.
- Supplier quality, validation/verification/release testing, and tools (FMEA, 8D, statistical software).
Work Schedule
- Onsite Mon–Fri; potential hybrid (3–4 days onsite/week) based on business needs.
How to Apply
- Submit resume and a brief cover note outlining relevant experience and interest.