Senior Quality Engineering Manager

Guardant Health • Redwood City, CA

5d • Hybrid

About The Position

The Senior Quality Engineering Manager plays a critical leadership role in overseeing quality activities associated with the design and development of new products, ensuring compliance with FDA, ISO, and other applicable IVD regulatory requirements. In addition, this role contributes to the development, maintenance, and continuous improvement of the company’s Quality Management System, supporting compliance with FDA Quality Management System Regulation (QMSR), ISO 13485, CLIA, CAP, and other relevant regulatory and accreditation standards.

Requirements

• Typically requires a bachelor’s with ~12+ years (or 8+ with master’s / 5+ with PhD / 3+ with PharmD/MD)
• 10+ years of quality experience in a n FDA/ISO regulated environment with at least 5+ years of design control experience
• 3+ years of strong Quality Management experience in an FDA/ISO regulated environment
• Experience in molecular biology products or molecular diagnostic products
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IVDR requirements
• Strong knowledge of design and development in accordance with ISO 13485/FDA 21 CFR 820 including Design Input/Output, Design Verification/Validation, Design Transfer and Risk Management
• Knowledge of applying statistical analysis for design of experiments, verification/validation
• Proven ability to influence stakeholders and drive product quality initiatives in a fast ‑ paced , deadline ‑ driven environment
• Strong analytical, problem ‑ solving , and communication skills

Nice To Haves

• ASQ CQE certification preferred

Responsibilities

• Provide strategic leadership and guidance on design controls across the design, development, and transfer of all products, ensuring performance and quality meet regulatory requirements and exceed customer expectations
• Develop, standardize, and apply Guardant Health’s design and development framework across all product development programs
• Lead and oversee all Product Risk Management Files, ensuring full compliance with ISO 14971
• Review and guide verification and validation strategies to ensure robust, compliant, and fit ‑ for ‑ purpose product evidence
• Serve as a subject matter expert on regulatory and international standards, providing interpretation and practical application across Guardant Health products
• Lead, mentor, and develop a high ‑ performing team of Quality Engineers supporting all aspects of IVD product development
• Partner cross ‑ functionally with Technology Development, Clinical Operations, Quality, Bioinformatics, Product, and Program Management teams to embed quality into product design, proactively manage risk, and support launch and commercialization milestones
• Coach and provide direction to project team members on design and development processes, design controls, and compliance with internal quality procedures
• Support design transfer activities to ensure successful handoff from development to manufacturing
• Ensure design changes are appropriately documented and executed in accordance with design change control procedures
• Ensure Design History Files are complete, accurate , and inspection ‑ ready prior to product transfer and global product launch
• Drive continuous improvement initiatives by identifying opportunities, partnering with leadership, and executing sustainable solutions
• Promptly report and document any concerns related to test quality or safety to appropriate leadership

Benefits

• Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time.
• flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior