Job Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Senior Quality Engineer, Supplier Quality plays an integral role in supporting supplier management activities and working with external suppliers and internal teams to assure that our products exceed the requirements and expectations of our customers and supports the company’s quality system activities that comply with the FDA’s Quality System Regulation, ISO 13485, CMDR as well as CLIA, CAP, and applicable state requirements.

Essential Duties and Responsibilities:

• Represent the organization as the primary contact for all suppliers that impact Guardant Health’s products and services
• Support Purchasing and Development teams in the evaluation and selection of best-in-class suppliers
• Responsible for supplier onboarding and and maintenance of approved supplier list (ASL)
• Communicate Guardant Health’s quality expectations to suppliers and partnering effectively with them to develop quality systems, processes, and controls to fulfil these expectations
• Monitor, analyze and identify trends from supplier quality and performance data, including supporting any scorecarding activities
• Drive failure analysis and supplier corrective action requests (SCAR) with suppliers
• Review supplier change requests, coordinate activities with suppliers and internal cross-functional support teams to qualify and support the change
• Development and certification of suppliers to achieve Dock to Stock status for supplied components
• Working closely with tier one suppliers to sustain and improve material/service quality
• Ensuring accurate and complete supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, and other miscellaneous quality documentation and records
• Supporting MRB/non-conforming material processes and sign off procedures
• Supporting supplier quality system audits, as required
• Support processes such as CAPA, nonconformances, and developing Quality metrics
• Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities
• 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. degree in Chemistry, Biology, Engineering, or a related scientific discipline
• 8 + years of quality experience in an FDA/ISO regulated environment
• Experience in supplier quality management and supplier agreements.
• Strong team player with demonstrated track record
• 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
• Knowledge of applicable GMP, FDA and ISO regulations and of other appropriate guidance documents / standards
• Travel: 25%

Additional Information

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $112,700 to $152,900. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

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 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

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.

All your information will be kept confidential according to EEO guidelines.

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