Senior Quality Engineer

Guardant Health seeks a Senior Quality Engineer to oversee quality activities for IVD product development and operations in compliance with FDA, ISO, and CLIA regulations. The role involves design controls, risk management, supplier oversight, and cross-functional guidance to ensure regulatory compliance and product quality.

Responsibilities

• 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

Requirements

• 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

Compensation: $114,600 - $157,600 base (Redwood City, CA primary location)