Guardant Health is a precision medicine company focused on guarding wellness and providing critical insights into cancer through advanced blood and tissue tests.
The Senior Quality Engineer plays a critical role in ensuring the quality and compliance of Guardant Health’s in vitro diagnostic (IVD) products throughout the product lifecycle. This role is a primary quality liaison for reagent development, providing expert guidance on Design Controls, Risk Management, Change Control, and Validation activities.
Requirements
B.S. degree in Engineering, Biology, Chemistry, Molecular Biology or a related scientific discipline
5+ years of quality experience in an FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred)
Working knowledge of design and development in accordance with ISO 13485/FDA 21 CFR 820, and other applicable regulations
Employees: 1001 - 5000
