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
The Denior/ Staff Quality Engineer plays an integral role in supporting quality activities related to IVD product development in accordance with FDA, ISO, CMDR and other IVD regulations. The individual 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:
- Provides design controls guidance/support for IVD projects in regards to User Requirements and Specification, System and Subsystem Requirements/Specifications, Design Verification and Validation, Test Method Validation, Risk Management, Design Transfer, Design Reviews and Product Lifecycle Management
- Leads all product Risk Management activities ensuring compliance with ISO 14971
- Ensures design changes are captured and follow the design change control process
- Provides Regulatory and International Standards guidance/support
- Provides guidance on stability testing, sample plan definition, and study development
- Manages and mentors junior quality engineers
- Ensures required documentation is completed prior to product transfers and worldwide product launches
- Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities
- Supports processes such as document control, nonconformances, CAPAs, and developing Quality metrics
- Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities
- Performs and documents internal audits and make recommendations for corrective actions
- Reports and documents concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable
- Performs related duties as assigned
This role works out of our Headquarters in Redwood City, CA. Due to the Covid 19 Pandemic Guardant Health has temporarily classified this role as ‘working from home status’, scheduled to return onsite at HQ when it is determined safe to do so.Qualifications
- Bachelor’s degree in Chemistry, Biology, Engineering or a related scientific discipline. ASQ CQE certification preferred.
- At least 8 years of quality experience in an FDA/ISO regulated environment
- Experience in molecular biology products or molecular diagnostic products
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IVDD, CLIA and CA requirements
- Experience in an IVD working environment
- Knowledge of applying statistical analysis for testing, process control, and design of experiments
- Strong team player
- 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 inter-personal skills
Employee may be required to lift routine office supplies and use office equipment. There may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
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.
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.
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