Guardant Health is a leading precision medicine company focused on transforming patient care and conquering cancer with data. Backed by Khosla, Lightspeed and Sequoia.
About the role
If the role is performed in Colorado, the pay range for this job is: $103,140 - $141,840 A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).
What they're looking for
- Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or a related scientific discipline
- 5+ years of quality experience in a FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred)
- Experience in molecular biology products or molecular diagnostic products
- Knowledge of applying statistical methods analysis for testing, process control, and design of experiments
- Hands-on experience with risk management, process validation, and change control
- Strong collaborator with demonstrated track record
More about this role
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook .
The Senior Quality Engineer plays an integral role in supporting quality activities related to IVD product development in accordance with FDA, ISO, and CMDR regulations. The Quality Engineer also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation and ISO 13485 as well as CLIA, CAP, and applicable state requirements.
- Point of contact for all quality activities related to the Guardant Health IVD development and Operations activities which include...
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