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 Quality Specialist supports various Quality Operations activities necessary for assuring the quality and compliance. Assists in organizing, creating, performing, reporting, storing or accessing documents for assigned tasks to complete a wide variety of deliverables. The Quality Specialist also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation, ISO 13485 as well as CLIA, CAP, and applicable state requirements. 

Essential Duties and Responsibilities:

• Assists with quality inspection of incoming material used for Guardant Health IVD product development and/or LDT testing to ensure continued compliance with internal procedures and applicable regulations
• Assists with creating incoming inspection records and maintains accurate documentation and/or any associated documentation for all quality activities according to internal requirements
• Assist in ensuring incoming material is adequately labeled, identified and segregated
• Assist in ERP transactions as required
• Owns and processes non-conformance, CAPA, and supports compilation of Quality metrics
• Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities
• Creates, reviews and improves standard operating procedures, work instructions and other documentation as needed
• Supports departmental inspection readiness and audit reponses as needed
• Represent Quality at cross functional meetings as needed
• Provides quality review support for batch records and supplier quality documents as assigned
• Ensure that all policies, procedures, and records are reviewed and approved
• Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as necessary

Qualifications

• Bachelors degree with 3+ years of Quality Assurance experience, or Master degree with one year of experience
• Working knowledge of FDA regulations and ISO 13485 standards required
• Knowledge of general Quality Assurance aspects of medical device GXPs and a familiarity with pertinent regualtions
• 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

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.

Covid Vaccination Policy:  Guardant Health requires all employees to be fully vaccinated. We follow the CDC guidelines for the definition of “fully vaccinated”, meaning an employee is consider fully vaccinated against COVID-19 after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination, and necessary booster vaccines. In addition, fully vaccinated employees will be required to maintain their fully vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters. Candidates may request and obtain an approved exemption from Guardant’s COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws.  Candidates will not be able to start their employment with Guardant until they show proof of vaccination or have an approved exemption.

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $70,400 to $96,000. The range does not