Senior Quality Engineer, Sustaining at Guardant Health in Redwood City, CA

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.

In pursuit of our goal to manage cancer across all stages of the disease, Guardant Health has launched two liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, and is developing programs for recurrence and early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

Job Description

Senior Quality Engineer - Sustaining

The Senior Quality Engineer, Sustaining plays an integral role in supporting quality activities related to product improvements and troubleshooting activities pertaining to our launched assays with next-generation sequencing. The Senior Quality Engineer, Sustaining 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.

Essential Duties and Responsibilities

• Primary point of contact for all quality activities related to sustaining and supporting the Guardant Health assays which includes providing guidance for Design Controls, Risk Management, and Change Control
• Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities
• Review quality deliverables, such as process/equipment verification / validation
• Use quality tools to implement improvements including: flowcharting, statistical process control, and trend analysis techniques
• Collaborate cross-functionally to ensure required activities are completed prior to transfers and launches
• Support processes such as CAPAs, and developing Quality metrics
• Perform 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

• Bachelor’s degree in Chemistry, Biology, Engineering or a related scientific discipline is required. Master’s degree preferred
• ASQ CQE certification preferred
• 5+ years of quality experience in a FDA/ISO regulated environment
• Knowledge of applying statistical analysis for testing, and process control
• Experience in molecular biology products or molecular diagnostic products is preferred
• Ability to work as an individual as well as in a team environment
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Excellent problem-solving and analytical skills
• Effective communication and interpersonal skills

Additional Information

Employee may be required to lift routine office supplies up to 20 lbs 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.

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.