Senior Quality Engineer

null, Vaud, ch
Company: Coopers
Category: Architecture and Engineering Occupations
Published on 2021-06-24 04:07:30

A leading and innovative company in the medical devices industry is looking for a 

Senior Quality Engineer


  • In charge of the product design, change request process.
  • Lead the operational quality activities (products release and non-conformity management)
  • Develop product expertise within the QA department to support the V&V activities linked to sterilization, packaging, and biocompatibility.
  • Monitor compliance to procedures, perform internal audits and update the Quality Management System.
  • Requirements

  • 5 years  of  QA experience  in a  Medical Device  company.
  • Significant knowledge of Quality Management System (ISO-13485, 21CFR part 820) and regulatory landscape ( MDD, MDR ).
  • Proven experience in leading a QA processes, preferably change control and NC/CAPA handling.
  • Significant experience in single use and reusable products validation with a deep understanding of ISO 10993-x, ISO 11135, ISO 17665-1, etc.
  • Strong ability to assess rationales for impact changes.
  • Experience in risk management as per ISO 14971.
  • Fluent in English.
  • Benefits

  • A highly attractive opportunity to join a fast-growing medical device company active in one of the most promising fields of medicine.
  • A dynamic atmosphere in an internationally minded environment.
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