Gilead Sciences · 21 hours ago
Sr Quality Engineer I
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$136K/yr - $176K/yr
4+ years expGilead Sciences is a company dedicated to improving global health by developing therapies for serious diseases. The Sr Quality Engineer I will play a crucial role in ensuring compliant processes are in place for the successful implementation of Gilead's combination product lifecycle management.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Develop key relationships and interface extensively with internal stakeholders to address and resolve quality and compliance issues related to drug-device combination products
Identify gaps in existing processes and lead cross-functional teams to develop and implement solutions
Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Work Instructions)
Work with management and department personnel to achieve goals and strategic initiatives
Identify, plan, and execute changes to quality processes to ensure conformance and continuous improvement
Ensure changes to commercial products comply with FDA QSR/QMSR, ISO 13485, and other applicable standards
Maintain compliance with global Risk Management processes in accordance with ISO 14971 and other applicable standards
Collaborate with SMEs from R&D, Clinical, and Operations to ensure comprehensive application of risk processes
Participate in annual product reviews and periodic updates of DHF and RMF
Maintain expertise in current and emerging requirements and quality trends for Pharmaceuticals, Medical Devices, and Combination Products worldwide
Support due diligence and internal/external audits or inspections as needed
Assist with complaint investigations and communicate findings to design, development teams, and CMOs
Stay abreast of evolving regulatory requirements to ensure compliance of commercial products
May support design and development activities as required
Qualification
Required
Bachelor's degree in science or engineering-related field with at least 6 years of experience in the medical device industry, OR Master's degree with at least 4 years of relevant experience
In-depth knowledge of Quality principles, concepts, industry practices, and standards
Quality experience in both clinical and commercial products
Strong understanding of U.S. and international quality systems regulations/standards
Ability to work independently and in a global team environment
Excellent interpersonal and communication skills
Preferred
Previous experience with combination devices (e.g., autoinjectors, pre-filled syringes)
Well-versed in risk management methodologies and tools (e.g., Hazard Analysis, FMEA)
Knowledge of ISO 14971 Risk Management processes
ASQ certifications (Certified Quality Auditor, Certified Quality Engineer, Certified Quality Manager) or equivalent
Familiarity with emerging regulatory requirements and ability to drive continuous improvement initiatives
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
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
2026-01-08
2026-01-07
2026-01-06
Company data provided by crunchbase