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

To support Guardant Health's leadership in the disruption of cancer treatments, the Quality and Regulation team is looking for an experienced and energetic Quality Engineer (QE) to help drive software quality and continuous improvement for an exceptional customer experience.

The Quality Engineer will be responsible for performing or reviewing software and computer system Verification and Validation (V&V), software risk assessments, audit remediation, and documentation authoring (SOPs, Work Instruction, FMEA, COTS/SOUP, Verification Validation Plan, Protocol, Report,traceability matrix, forms, etc...) in accordance to the relevant US FDA regulations, Medical Device regulations in other markets and relevant international standards. In addition, the QE will work on other software components of the Guardant software stack and ensure that the software verification and validation is complete, the product is safe and of high quality, and meets all regulatory 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.
• Provides guidance on stability testing, sample plan definition, and validation study development.
• 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.
• Leads all Risk Management and Change Control 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 and document internal audits and make recommendations for corrective actions.
• 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 leading risk management activities per ISO 14971:2019  and A11:2021.
• 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 interpersonal skills.
• ASQ CQE certification preferred.
• Employee may be required to lift routine office supplies and use office equipment.
• The 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.

#LI-AH1

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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 sci