21 Oct
Quality Engineer II /Senior Quality Engineer -Early Detection
California, Usca 00000 Usca USA

Vacancy expired!

Job Description

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

Essential Duties and Responsibilities:

  • Provides design controls guidance/support for IVD projects in regards to User Requirements and Specification, System and Subsystem Requirements/Specifications, Design Verification and Validation, Test Method Validation, Risk Management, Design Transfer, Design Reviews and Product Lifecycle Management
  • Lead all product Risk Management activities ensuring compliance with ISO 14971
  • Ensures design changes are captured and follow the design change control process
  • Provides Regulatory and International Standards guidance/support
  • Provides guidance on stability testing, sample plan definition, and study development
  • Manages and mentors junior quality engineers
  • Ensures required documentation is completed prior to product transfers and worldwide product launches
  • Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities
  • Supports processes such as document control, nonconformances, CAPAs, and developing Quality metrics
  • Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities
  • Performs and document internal audits and make recommendations for corrective actions
  • Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable
  • Perform related duties as assigned

The hired candidatehas the option to work remotely. Must be willing and available to travel to Guardant Health's headquarters in Redwood City, CA at least a few times per year.

Qualifications

  • Bachelor’s degree in Chemistry, Biology, Engineering or a related scientific discipline.ASQ Certified Quality Engineer preferred.
  • 5 years of recent experience in an in vitro diagnostic (IVD) or medical device company
  • 5+ years of quality experience in an FDA/ISO regulated environment
  • Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IVDD, CLIA and CA requirements
  • 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

Additional Information

Work Environment:

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 exposure to high noise levels, fumes, and 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 and will not be discriminated against on the basis of disability.

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

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Vacancy expired!


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