Quality Systems Engineer NPI

Organization
Cepheid - US
Job Location
Sunnyvale, CA 94089
Job Description

The Quality Systems Engineer, NPI, will support quality systems activities related to the development of new assays and reagents. Key responsibilities will include design control and the development of validation master plans in compliance with FDA/ISO regulations. The ideal candidate will have a Quality Engineering background in the IVD/medical device industry and possess a sound understanding of Quality Systems to influence robust reagent development and its associated test methods.

  • Participate as core team member from Quality on new product development projects focusing on design control, design review, validation, risk management, stability studies, product life cycle compliance, and continuous process improvement.
  • Provide guidance to cross-functional teams on stability testing, test methods, and validations to ensure products meet customer, regulatory, and business requirements.
  • Independently prepare project-specific Master Validation Plans to include material, process, and test method validation requirements.
  • Define and conduct product investigations.
  • Analyze test results and work with teams to prepare reports.
  • Communicate with suppliers to ensure requirements are understood and component/product performance is appropriately managed.
  • Review and approve records and documents for compliance with QSR and Company requirements.
  • Collaborate with stakeholders to continuously improve the Quality Systems focusing on process excellence.

 

 

  • Bachelor's Degree in Biochemistry, Molecular Biology Microbiology, or related Physical or Biological scientific field; or, equivalent combination of education and experience to perform at this level.
  • Minimum 5 years of experience in Quality Engineering, Quality Assurance, Quality Control, Product Development, or Product Transfer working with assays/reagents in medical device or biotech environment.
  • Strong knowledge of process and methods validation for reagent assay products.
  • Exceptionally strong team player with excellent interpersonal and communication skills in technical writing.
  • Detail oriented with strong organizational skills and high quality
  • Strong self-initiative and ability to manage concurrent projects.
  • Excellent problem solving and analytical skills.
  • Proficiency with Word, Excel, Power Point, Project, and electronic documentation systems (Agile or similar system).

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