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Guardant Health focused on rare-cell diagnostics
Engineering, Full Time       Posted: Tuesday, November 27, 2018
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  Company Description


We believe conquering cancer is a big data problem. That's why we built the world's leading comprehensive liquid biopsy. This non-invasive tool for accessing & sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries & new products. We're working on some exciting ones, including in early detection, where the impact on patients can be profound. We've raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, & SoftBank.

Job Description

About this role:

The Sr. 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.

  • Primary point of contact for all quality activities related to the Guardant Health IVD development activities which includes providing guidance for Design Controls, Risk ManagementAnalysis, & 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
  • Performsother related duties & responsibilities as assigned
  • Report & document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
  • Bachelor'sdegree in Chemistry, Biology, Engineering or a related scientific discipline
  • 5+ years of quality experience in a FDA/ISO regulated environment
  • Experience ininmolecular 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
Additional Information
  • ASQ CQE certification preferred
  • Industry Experience
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