Senior Quality Engineer
Guardant Health · Redwood City, CA +1 more
QualityFull-time$115k–$158kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Guardant Health seeks a Senior Quality Engineer to lead quality activities for IVD product development and operations. The role involves ensuring FDA, ISO, and CMDR compliance while supporting supplier management, validation studies, and cross-functional product implementation initiatives.
What they're looking for
- Bachelor's degree in Chemistry, Biology, Engineering, Molecular Biology, or related scientific discipline
- 5+ years quality experience in FDA/ISO regulated environment, IVD or molecular diagnostics preferred
- Experience with molecular biology or molecular diagnostic products
- Knowledge of statistical methods for testing, process control, and design of experiments
- Hands-on experience with risk management, process validation, and change control
- Working knowledge of ISO 13485, 21 CFR 820, IVDD, CLIA, and CAP requirements
- ASQ CQE certification preferred
What you'll be doing
- Serve as primary contact for quality activities in IVD development and operations, providing guidance on design controls and risk management
- Lead supplier management program including collaborations, agreements, and oversight activities
- Guide stability testing, sample planning, and validation study development
- Lead risk management and change control activities across product development initiatives
- Perform internal and external audits with documentation of findings and corrective action recommendations
Privacy & handoff
This role links to Guardant Health's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.