Quality Systems Specialist II

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

This Quality System Specialist is responsible for supporting activities in developing, validating and supporting new product introductions for Cepheid components and products. The Quality Systems Specialist applies knowledge of design control principles and product evaluation techniques to positively influence the development of new products and to ensure they are developed and manufactured in accordance with regulatory and customer requirements. This position interacts with personnel at all levels and departments in the company to ensure full compliance with all product requirements and specifications to meet both company and customer expectations.

Responsibilities:

  • Participate as the Quality representative on select new product development teams
  • Provide guidance to ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specifications and procedure development, risk management, stability studies, and design review
  • Analyze and interpret complicated data sets
  • Participate in communications 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

 

  • Bachelor's Degree in Biochemistry, Biology, or related physical or Biological Science field, or equivalent experience
  • Minimum of 6 years of combined experience in Quality Assurance, Quality Control, Product Development, or Product Transfer in a regulated (medical device/biotech) development and manufacturing environment
  • Excellent problem solving and analytical skills
  • Strong knowledge of process validation for reagent assay products

  • Experience with application of the principles of statistical analysis

  • Computer proficiency essential, e.g., Word, Excel, Power Point, Microsoft Project, Minitab, JMP, electronic documentation systems

  • 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

 

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