Sr Quality Engineer II - Combination Products
Gilead Sciences
5 months ago
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 on new combination product development, supporting design verification, design validation, and technology transfer.
- Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead Quality System requirements.
- Plan, implement, and track quality improvement initiatives and ensure timely execution of action items/deliverables.
- Interface with cross-functional teams, contract manufacturers, and suppliers to resolve complex technical/quality issues for drug-device combination products and manufacturing processes.
- Act as an escalation point for complex, high-impact quality issues, risks, and decisions.
- Support and strengthen 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 + at least 8 years of relevant experience, OR Master’s degree in related field + at least 6 years of relevant experience.
- Demonstrated Quality Assurance experience for medical devices and/or drug-device combination products.
- Excellent verbal, written, and interpersonal communication skills; able to influence across functions.
Preferred Qualifications
- 10+ 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.
- Working knowledge of domestic/international quality system regulations; ability to drive continuous improvement.
- Statistical methods foundation (normality testing, capability analysis, tolerance intervals, test method validation including MSA, Gage R&R).
- Advanced ISO 14971 risk management (FMEA, system-level risk analysis, hazard analysis—expertise in at least one area).
- Ability to develop/evolve complex quality concepts, standards, and methodologies.
- Strong knowledge of medical device and/or combination product manufacturing operations.
Compensation/Benefits
- Salary range: $157,590.00 - $203,940.00.
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package (company-sponsored medical, dental, vision, and life insurance plans).
Application Instructions
- 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 on new combination product development, supporting design verification, design validation, and technology transfer.
- Ensure compliance with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead Quality System requirements.
- Plan, implement, and track quality improvement initiatives and ensure timely execution of action items/deliverables.
- Interface with cross-functional teams, contract manufacturers, and suppliers to resolve complex technical/quality issues for drug-device combination products and manufacturing processes.
- Act as an escalation point for complex, high-impact quality issues, risks, and decisions.
- Support and strengthen 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 + at least 8 years of relevant experience, OR Master’s degree in related field + at least 6 years of relevant experience.
- Demonstrated Quality Assurance experience for medical devices and/or drug-device combination products.
- Excellent verbal, written, and interpersonal communication skills; able to influence across functions.
Preferred Qualifications
- 10+ 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.
- Working knowledge of domestic/international quality system regulations; ability to drive continuous improvement.
- Statistical methods foundation (normality testing, capability analysis, tolerance intervals, test method validation including MSA, Gage R&R).
- Advanced ISO 14971 risk management (FMEA, system-level risk analysis, hazard analysis—expertise in at least one area).
- Ability to develop/evolve complex quality concepts, standards, and methodologies.
- Strong knowledge of medical device and/or combination product manufacturing operations.
Compensation/Benefits
- Salary range: $157,590.00 - $203,940.00.
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package (company-sponsored medical, dental, vision, and life insurance plans).
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.