Senior Device Quality Engineer
GSK
July 02, 2026
Remote friendly (Zebulon, NC)
United States
Operations
Position Summary
- Ensure products meet safety, regulatory, and quality standards throughout the product lifecycle for medical devices within combination products (design/development through post-market surveillance), including risk management, root cause analyses, process validation, and maintenance of Design and Development Files (DDF).
Responsibilities
- Ensure compliance with FDA, ISO, EU MDR, global, and GSK requirements.
- 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/intro.
- Support process improvements and validations; ensure manufacturing compliance for filling, assembly, and packaging.
- Lead investigations for nonconformances, deviations, and complaints.
- Monitor and trend device process KPIs; identify risks and develop mitigation strategies focused on patient safety and quality.
- Lead readiness for device-related inspections; act as SME for regulatory inspections/audits.
- Partner with suppliers/internal teams to resolve component quality issues; support supplier quality management.
- Support device lifecycle management (continuous improvement, design changes, post-market quality monitoring) and DDF compliance.
- Provide SME guidance to operations, engineering, and quality teams.
Basic Qualifications (Required)
- BA/BS in scientific/engineering/technical discipline, with demonstrated medical device expertise (or equivalent education/experience).
- 8+ years relevant industry experience (pharmaceutical/biopharmaceutical/related) with medical device manufacturing and quality oversight.
- Hands-on experience with investigations, root cause analysis, and CAPA.
- Working knowledge of QMS and cGMP.
Preferred Qualifications
- Audit/regulatory inspection support experience.
- Experience overseeing pre-filled syringe and autoinjector assembly processes.
- Design controls, risk management, DDF/DHF knowledge; global regulatory understanding.
- Change control, process validation, investigations, root cause analysis, CAPA.
- Advanced degree (Engineering/Biomedical Engineering or related).
- Human factors and ISO 14971 experience.
- U.S. device standards/regulatory familiarity.
- Supplier quality background; validation/verification/release testing; FMEA/8D/statistical tools.
Work Schedule
- On-site Monday–Friday; 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.
- Ensure products meet safety, regulatory, and quality standards throughout the product lifecycle for medical devices within combination products (design/development through post-market surveillance), including risk management, root cause analyses, process validation, and maintenance of Design and Development Files (DDF).
Responsibilities
- Ensure compliance with FDA, ISO, EU MDR, global, and GSK requirements.
- 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/intro.
- Support process improvements and validations; ensure manufacturing compliance for filling, assembly, and packaging.
- Lead investigations for nonconformances, deviations, and complaints.
- Monitor and trend device process KPIs; identify risks and develop mitigation strategies focused on patient safety and quality.
- Lead readiness for device-related inspections; act as SME for regulatory inspections/audits.
- Partner with suppliers/internal teams to resolve component quality issues; support supplier quality management.
- Support device lifecycle management (continuous improvement, design changes, post-market quality monitoring) and DDF compliance.
- Provide SME guidance to operations, engineering, and quality teams.
Basic Qualifications (Required)
- BA/BS in scientific/engineering/technical discipline, with demonstrated medical device expertise (or equivalent education/experience).
- 8+ years relevant industry experience (pharmaceutical/biopharmaceutical/related) with medical device manufacturing and quality oversight.
- Hands-on experience with investigations, root cause analysis, and CAPA.
- Working knowledge of QMS and cGMP.
Preferred Qualifications
- Audit/regulatory inspection support experience.
- Experience overseeing pre-filled syringe and autoinjector assembly processes.
- Design controls, risk management, DDF/DHF knowledge; global regulatory understanding.
- Change control, process validation, investigations, root cause analysis, CAPA.
- Advanced degree (Engineering/Biomedical Engineering or related).
- Human factors and ISO 14971 experience.
- U.S. device standards/regulatory familiarity.
- Supplier quality background; validation/verification/release testing; FMEA/8D/statistical tools.
Work Schedule
- On-site Monday–Friday; 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.