Sr. Quality Engineer I- Combination Products
Gilead Sciences · Foster City, CA
QualityFull-time$136k–$176kCompany career page
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What they're looking for
- Bachelor's degree in Engineering or science with 6+ years relevant experience, or Master's with 4+ years
- Demonstrated quality assurance experience with medical devices or drug-device combination products
- Strong verbal, written, and interpersonal communication skills with cross-functional influence ability
- Knowledge of FDA 21 CFR Part 820, Part 4, ISO 13485, and ISO 14971 regulatory requirements
- Project management and process improvement capabilities in regulated environments
- Statistical methods proficiency including capability analysis, MSA, and Gage R&R
- Advanced risk management expertise per ISO 14971, including FMEA and hazard analysis
What you'll be doing
- Lead quality engineering for combination product development programs with focus on design controls and risk management
- Partner with device engineering on design verification, validation, and technology transfer activities
- Ensure regulatory compliance with applicable FDA and ISO standards throughout product lifecycle
- Interface with cross-functional teams, contract manufacturers, and suppliers to resolve quality and technical issues
- Develop, review, and approve controlled documentation including protocols, risk analyses, and test methods
Privacy & handoff
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