Staff 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 Staff 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 and Process Validation in alignment with FDA regulations (21 CFR 820), ISO 13485, CLIA, CAP, and other global standards. The ideal candidate will 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, verification/validation and design transfer. 
• Define and apply quality requirements for reagent manufacturing processes and quality control activities as it relates to process validations and test method validations. 
• Provide guidance on Production and Process Controls, sampling plans, and reagent stability testing requirements. 
• Lead Risk Management activities and ensure effective integration into design and process decisions. 
• Lead process change assessments related to manufacturing process and reagent qualification changes. 
• Support design transfer from development to manufacturing, ensuring readiness and compliance for commercial scale-up. 
• Collaborate with Technical Development, Operations and Quality Control teams to proactively address quality issues in design and manufacturing. 
• Support internal audits, manage CAPAs, supplier changes, and nonconformance investigations related to reagents. 
• Support equipment qualifications (IQ/OQ/PQ) for manufacturing and quality control. 
• 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, or a related scientific discipline. 
• Minimum 8 years of Quality Engineering experience in FDA/ISO regulated environment (IVD preferred). 
• Deep knowledge of Design Controls, Risk Management, Validation, and Design Transfer. 
• Strong understanding of ISO 13485, ISO 14971, 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. 
• Ability to support multiple projects with cross-functional stakeholders in a fast-paced environment.  
• Excellent problem-solving, analytical, and communication skills.

Additional Information

Hybrid Work Model: At Guardant Health, we have