Gilead Sciences · 18 hours ago
Senior Quality Engineer I - Combination Product Development
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$136K/yr - $176K/yr
4+ years expGilead Sciences is dedicated to creating a healthier world by tackling diseases and developing life-changing therapies. The Senior Quality Engineer will lead quality engineering efforts for medical device combination product development, focusing on design control, risk management, and ensuring compliance with relevant regulations.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Serve as a lead quality engineer for medical device combination product development projects, with a strong emphasis on design control and risk management activities
Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities
Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO 13485, ISO 14971, and Gilead’s quality system requirements. Plan and implement approved quality improvement action items and deliverables
Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex technical issues related to drug-device combination products, processes, and quality
Act as an escalation point for complex and high-impact quality issues, concerns, and decisions
Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs)
Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments
Develop and/or review controlled documents (e.g., protocols, reports, plans, risk analyses, specifications, test methods)
Qualification
Required
Bachelor's degree in engineering or a scientific discipline with at least 6 years of relevant experience, OR a Master's degree in a relevant field with at least 4 years of relevant experience
Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products
Excellent verbal, written, and interpersonal communication skills
Preferred
Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes) is preferred
Strong project management and process improvement skills
Understanding of domestic and international quality system regulations and the ability to drive continuous improvement
Possess a strong foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, GageR&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these areas is required
Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles and theories
Strong knowledge of medical devices and or combination products manufacturing
Benefits
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-09
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2026-01-07
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