<p>Company Description</p> <p>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.</p> <p>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.</p> <p>Essential Duties and Responsibilities:</p> <ul> <li> <p>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</p> </li><li> <p>Develop, standardize, and apply Guardant Health's design and development framework across all product development programs</p> </li><li> <p>Lead and oversee all Product Risk Management Files, ensuring full compliance with ISO 14971</p> </li><li> <p>Review and guide verification and validation strategies to ensure robust, compliant, and fit-for-purpose product evidence</p> </li><li> <p>Serve as a subject matter expert on regulatory and international standards, providing interpretation and practical application across Guardant Health products</p> </li><li> <p>Lead, mentor, and develop a high-performing team of Quality Engineers supporting all aspects of IVD product development</p> </li><li> <p>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</p> </li><li> <p>Coach and provide direction to project team members on design and development processes, design controls, and compliance with internal quality procedures</p> </li><li> <p>Support design transfer activities to ensure successful handoff from development to manufacturing</p> </li><li> <p>Ensure design changes are appropriately documented and executed in accordance with design change control procedures</p> </li><li> <p>Ensure Design History Files are complete, accurate, and inspection-ready prior to product transfer and global product launch</p> </li><li> <p>Drive continuous improvement initiatives by identifying opportunities, partnering with leadership, and executing sustainable solutions</p> </li><li> <p>Promptly report and document any concerns related to test quality or safety to appropriate leadership</p> </li></ul> <p>Qualifications:</p> <ul> <li> <p>Typically requires a bachelor's with ~12+ years (or 8+ with master's / 5+ with PhD / 3+ with PharmD/MD).</p> </li><li> <p>10+ years of quality experience in an FDA/ISO regulated environment with at least 5+ years of design control experience</p> </li><li> <p>3+ years of strong Quality Management experience in an FDA/ISO regulated environment</p> </li><li> <p>Experience in molecular biology products or molecular diagnostic products</p> </li><li> <p>Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IVDR requirements</p> </li><li> <p>Strong knowledge of design and development in accordance with ISO 13485/FDA</p> </li><li> <p>21 CFR 820 including Design Input/Output, Design Verification/Validation,</p> </li><li> <p>Design Transfer and Risk Management</p> </li><li> <p>Knowledge of applying statistical analysis for design of experiments, verification/validation</p> </li><li> <p>ASQ CQE certification preferred</p> </li><li> <p>Proven ability to influence stakeholders and drive product quality initiatives in a fast-paced, deadline-driven environment</p> </li><li> <p>Strong analytical, problem-solving, and communication skills</p> </li></ul> <p>Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.</p> <p>The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate's compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need.</p> <p>Primary Location: Redwood City, CA Primary Location Base Pay Range: $160,000 - $220,000 Other US Location(s) Base Pay Range: $136,000 - $187,000 If the role is performed in Colorado, the pay range for this job is: $144,000 - $198,000</p> <p>Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.</p> <p>Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to Peopleteam@guardanthealth.com</p> <p>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).</p> <p>Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.</p> <p>All your information will be kept confidential according to EEO guidelines.</p> <p>To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.</p> <p>Please visit our career page at: http://www.guardanthealth.com/jobs/</p>