Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Quality Engineer plays an integral role in supporting quality activities related to IVD product development in accordance with FDA, ISO, & CMDR regulations.
- Primary point of contact for all quality activities related to the Guardant Health IVD product development to ensure continued compliance with internal procedures & applicable regulations;
- Responsible for effective & robust risk management for products & processes;
- Responsible for assessment of deliverables against Design Control, DHF, labeling & technical file requirements;
- Provide guidance on component & system level specifications relative to customer needs & product performance specifications;
- Provide effective support for multiple projects, balancing priorities & resources appropriately to meet both project & management expectations;
- Provide guidance on reagent manufacturing, process validation, design transfer, & change control;
- Provide guidance on verification & validation testing & troubleshooting activities;
- Work closely with cross-functional teams responsible for implementation of new products & process improvements;
- Support processes such as document control, training, nonconformance, CAPA, & developing Quality metrics;
- Identifies opportunities for continual improvement & works with management & team members to successfully address these opportunities;
- Perform & document internal audits & make recommendations for corrective actions;
- Report & document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable;
- Perform other related duties & responsibilities as assigned;
- B.S. degree in Chemistry, Biology, or a related scientific discipline
- A minimum of 3years of experience in Design Quality
- Experience in molecular biology products or molecular diagnostic products
- Experience in reagent manufacturing processes & design transfer
- Knowledge of applying statistical analysis for process control & design of experiments
- Ability to successfully balance & prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Strong team player with demonstrated track record
- Excellent problem-solving & analytical skills
- Effective communication & inter-personal skills
- Takes initiative & responsibility for professional growth & education/training
- GCLP or GCP experience is a plus
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & 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 & will not be discriminated against on the basis of disability.
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