Sr. Quality Engineer I- Combination Products
Gilead Sciences
September 03, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Key Responsibilities:
- Serve as a Lead Quality Engineer for medical device combination product development programs, focusing on design controls, risk management, and lifecycle quality oversight.
- Partner with Device Engineering to support design verification, design validation, and technology transfer for new combination products.
- Ensure compliance with applicable regulatory requirements and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead Quality System requirements.
- Plan, implement, and track approved quality improvement initiatives.
- Interface with internal cross-functional teams, contract manufacturers, and suppliers to resolve complex technical and quality issues.
- Act as an escalation point for complex, high-impact quality issues, risks, and decisions.
- Support strategic relationships with internal stakeholders and Contract Manufacturing Organizations (CMOs).
- Provide quality guidance and impact assessments for change controls, including evaluations of Design History Files (DHF) and Risk Management Files (RMF).
- Develop, review, and approve controlled documentation (protocols, plans, reports, risk analyses, specifications, test methods).
Basic Qualifications:
- Bachelor’s degree in Engineering or a scientific discipline with at least 6 years’ relevant experience, OR Master’s degree with at least 4 years’ relevant experience.
- Demonstrated Quality Assurance experience for medical devices and/or drug-device combination products.
- Excellent verbal, written, and interpersonal communication skills; ability to influence across functions.
Preferred Qualifications:
- 8+ years supporting combination products (e.g., autoinjectors, pre-filled syringes, co-packaged kits) with expertise in design controls and risk management.
- Strong project management and process improvement skills.
- Knowledge of domestic and international quality system regulations; drive continuous improvement.
- Statistical methods foundation (normality testing, capability analysis, tolerance intervals, test method validation; MSA, Gage R&R).
- Advanced ISO 14971 risk management (FMEA, system-level risk analysis, hazard analysis).
- Knowledge of medical device and/or combination product manufacturing operations.
Application Instructions:
- For current employees and contractors: apply via the Internal Career Opportunities portal in Workday.
- Serve as a Lead Quality Engineer for medical device combination product development programs, focusing on design controls, risk management, and lifecycle quality oversight.
- Partner with Device Engineering to support design verification, design validation, and technology transfer for new combination products.
- Ensure compliance with applicable regulatory requirements and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead Quality System requirements.
- Plan, implement, and track approved quality improvement initiatives.
- Interface with internal cross-functional teams, contract manufacturers, and suppliers to resolve complex technical and quality issues.
- Act as an escalation point for complex, high-impact quality issues, risks, and decisions.
- Support strategic relationships with internal stakeholders and Contract Manufacturing Organizations (CMOs).
- Provide quality guidance and impact assessments for change controls, including evaluations of Design History Files (DHF) and Risk Management Files (RMF).
- Develop, review, and approve controlled documentation (protocols, plans, reports, risk analyses, specifications, test methods).
Basic Qualifications:
- Bachelor’s degree in Engineering or a scientific discipline with at least 6 years’ relevant experience, OR Master’s degree with at least 4 years’ relevant experience.
- Demonstrated Quality Assurance experience for medical devices and/or drug-device combination products.
- Excellent verbal, written, and interpersonal communication skills; ability to influence across functions.
Preferred Qualifications:
- 8+ years supporting combination products (e.g., autoinjectors, pre-filled syringes, co-packaged kits) with expertise in design controls and risk management.
- Strong project management and process improvement skills.
- Knowledge of domestic and international quality system regulations; drive continuous improvement.
- Statistical methods foundation (normality testing, capability analysis, tolerance intervals, test method validation; MSA, Gage R&R).
- Advanced ISO 14971 risk management (FMEA, system-level risk analysis, hazard analysis).
- Knowledge of medical device and/or combination product manufacturing operations.
Application Instructions:
- For current employees and contractors: apply via the Internal Career Opportunities portal in Workday.