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Guardant Health // rare-cell diagnostics
 
, Full Time       Posted: Wednesday, March 04, 2020
 
   
 
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Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & 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 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.

Job Description

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

Essential Duties & 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, & decisions on product development activities to ensure continued compliance with internal procedures & applicable regulations
  • Provides guidance on stability testing, sample plan definition, & validation study development
  • Ensures required documentation is completed prior to product transfers & product launches
  • Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, & troubleshooting activities
  • Leads all Risk Management & Change Control activities
  • Support processes such as document control, training, CAPAs, & developing Quality metrics
  • Identifies opportunities for continual improvement & works with management & team members to successfully address these opportunities
  • Perform & document internal audits & make recommendations for corrective actions
  • Perform other related duties & responsibilities as assigned
  • Report & 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, & design of experiments
  • Strong team player with demonstrated track record
  • Ability to successfully balance & prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
  • Excellent problem-solving & analytical skills
  • Effective communication & inter-personal skills
  • ASQ CQE certification preferred

Work Environment:

Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Additional Information

Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & 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 & will not be discriminated against on the basis of disability.

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

To learn more about the information collected when you apply for a position at Guardant Health & how it is used, please review ourPrivacy Notice for Job Applicants.

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