Quality Engineer
Spring Professional
Nyon, CH
vor 5 Tg.

Our Client, an International Medical Device Company, is recruiting on a temporary contract 7 months a

Your Responsibilities

Main purpose of the role :

  • Support and improve quality system management in compliance (ISO 9001, ISO 13485, QSR 21 CFR 820, ...) and promote
  • Support any improvement project from quality perspective
  • Participate to third parties audits (Bodies notified, authorities,
  • Promote quality system and approach in the company
  • Responsibilities :

  • Support and improve quality system management in compliance with applicable requirements (ISO 9001, ISO 13485, QSR 21 CFR 820, ...)
  • Promote continuous improvement process ( non-conformity, CAPA and Change management)
  • Support R&D project and improvement project from quality perspective specially for risk management process and any quality impact on design process
  • Participate to third parties audits (Bodies notified, authorities, ISO 13485, FDA, etc)
  • Manage the Continuous Improvement Plan
  • Promote quality system and approach in the company.
  • Your Profile

  • Quality engineer or equivalent
  • Minimum of 3 years experience in the medical device industry
  • Knowledge of the requirements relative to the ISO13485, European directive 93 / 42 and 21 CFRpart 820
  • Continuous improvement experience
  • Good skills for communication and coordination
  • Knowledge of the usual computing tools
  • Fluency in French and English mandatory
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