Senior Quality Engineer

Company Description

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.

Job Description

The Senior Quality Engineer, Reagents plays a critical role in ensuring the quality and compliance of Guardant Health’s in vitro diagnostic (IVD) products across the product lifecycle – from early design and development to manufacturing and supplier collaboration. This role serves as a primary quality liaison for reagent development, offering expert guidance on Design Controls, Risk Management, Process Validation, and Change Control. The Senior Quality Engineer also supports the Quality Management System (QMS) in alignment with FDA regulations (21 CFR 820), ISO 13485, CLIA, CAP, and other global standards. The ideal candidate will have a strong background in process validation and equipment qualification in a reagent manufacturing environment, drive continuous improvement, ensure design robustness, and enable seamless design transfer of high-quality, compliant reagent products.  
 

Essential Duties and Responsibilities: 

• Lead Design Quality Engineering efforts for reagent product development, including phase design reviews, risk assessments, and design verification/validation. 
• Define and apply quality requirements for reagent manufacturing processes and quality control activities. 
• Provide guidance on Production and Process Controls, sampling plans, and reagent stability testing requirements. 
• Lead Risk Management activities per ISO 14971 and ensure effective integration into design and process decisions. 
• Lead Change Control assessments related to reagent formulations, manufacturing process changes, reagent qualification changes, and supplier updates. 
• Support design transfer from development to manufacturing, ensuring readiness and compliance for commercial scale-up. 
• Support equipment qualification (IQ/OQ/PQ) and test method validation for reagent manufacturing and quality control. 
• Collaborate with Technical Development, Operations, Quality Control, and Regulatory Affairs teams to proactively address quality issues in design and manufacturing. 
• Conduct and document internal audits, manage CAPAs, and support nonconformance investigations related to reagents. 
• Promote a culture of quality and compliance through training, mentoring, and cross-functional engagement. 
• Performs other related duties and responsibilities as assigned. 
• Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable. 

Qualifications

• B.S. in Engineering, Biology, Chemistry, Molecular Biology or a related scientific discipline. 
• Minimum 5+ years of Quality Engineering experience in FDA/ISO regulated environment (IVD, medical devices, or reagent-based preferred). 
• Deep knowledge of Design Controls, Risk Management, Validation, and Design Transfer. 
• Strong understanding of ISO 13485, FDA 21 CFR 820, and applicable global regulations. 
• Experience in statistical analysis, Design of Experiments (DoE), and sampling plans for reagent processes. 
• Working knowledge of GMPs, reagent formulation, and stability testing.