Gilead Sciences · 8 hours ago
Sr Quality Engineer I
San Francisco Bay Area
Full-time
Onsite
Senior Level
$136K/yr - $176K/yr
6+ years expGilead Sciences is a company dedicated to creating a healthier world by tackling major diseases and developing innovative therapies. The Sr Quality Engineer I will play a crucial role in supporting new combination products in the commercial stage, ensuring end-to-end quality support and collaborating with design and development teams on Design Transfer.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to address and resolve technical issues related drug-device combination product, process and quality issues
Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
Writes and or implement changes to controlled documents (e.g., SOPs, Specifications, WIs, etc.) as needed
Create, revise, execute SOPs to support combination product quality governance during the Design Transfer or in the commercial stage
Work with management and department personnel to achieve goals and strategic initiatives
Executes changes to quality processes to ensure conformance and continuous improvement
Ensure that changes to commercial products are conducted in accordance with FDA QSR/QMSR, ISO 13485, and other applicable standards
Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards
Work cross-functionally with Subject Matter Experts from R&D, Clinical, and Operations to ensure the risk process is applied comprehensively
Participate in annual product reviews and perform periodic review and update of DHF and RMF
Review design inputs, outputs, and verification/validation results
Analyze process data and ensure processes are capable and in control
Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide
Supports due diligence and internal or external audits/inspections as needed
Create and provide Quality training as needed for cross functional stake holders and CMOs
Support complaints investigations and filter information back to the design and development team and CMOs
Stay abreast of evolving regulatory requirements and ensure commercial products comply with applicable standards
Qualification
Required
Must have 6+ years of experience in the medical device industry and a Bachelor's degree in science or engineering related field OR 4+ years of relevant experience with a Master's degree
Demonstrates in-depth knowledge of Quality principles, concepts, industry practices, and standards
Previous experience with combination devices is preferred (i.e., Autoinjectors, pre-filled syringes)
Previous experience in Design Transfer to contract manufacturers
Quality experience in both clinical and commercial products
Well-versed in risk management methodologies and their application
Able to work independently and in a global team environment, and with all levels of personnel within the organization
Possess excellent interpersonal relationship skills
Demonstrates understanding of U.S. and international quality systems regulations/standards to adopt best in class systems/processes and drive continuous improvement initiatives
Preferred
Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis / or Failure Mode Effects Analysis (FMEA)) is preferred
Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred
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
2026-01-13
Company data provided by crunchbase