Senior Quality Engineer

Company 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 plays an integral role in supporting quality activities related to IVD product development in accordance with FDA, ISO, and CMDR regulations.  The Quality Engineer also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation and ISO 13485 and ISO 14971, as well as CLIA, CAP, and applicable state requirements.

Essential Duties and Responsibilities:

• Primary point of contact for all quality activities related to the Guardant Health IVD development activities which includes providing guidance for Design Controls, Risk Management, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations
• Support design verification and validation test plans, protocols, procedures and reports and participate in cross functional design reviews
• Review and approval of change management activities and assess change impact
• Lead pre and post market risk assessments including Hazard Analysis/dFMEA/pFMEA
• Ensures Design History File and and Risk Management File documentation is present, compliant, and maintained
• Ensures Risk Management Files are integrated into complaints management process, CAPA, MDR, and post market surveillance
• Ensures required documentation is completed prior to product transfers and product launches
• Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities
• Support processes such as document control, training, CAPAs, and developing Quality metrics
• Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities
• 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
• 5+ years of quality experience in a FDA/ISO regulated environment
• Experience in molecular biology products or molecular diagnostic products
• Knowledge of applying statistical analysis for testing, process control, and design of experiments
• 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
• ASQ CQE certification preferred

#LI-AH1

#LI-Hybrid

Additional Information

Hybrid Work Model: At Guardant Health, we have 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.

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $100,000 to $135,000. 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 e