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Global Devices Quality System Specialist (m/f)

Administration / Secretarial
Bulle
English

Medical Device team in UCB is a Global team that works on the design and creation of innovative device for patients. Randstad is proud to contribute in such a wonderful 12 initial months mission.

Your mission:


  • Maintain and develop a high standard quality system considering requirements such as ISO13485, ISO14971 and 21CFR820
  • Ensure QMS adequacy for diverse products development and lifecycle activities including KPIs management
  • Actively support the QMS in an evolving environment
  • Be a driver in communication to facilitate understanding of every stakeholder
  • Work as a leader for quality subjects regarding operations and projects

Requirements:

Your profile:

  • A scientific or engineering background;
  • At least 3 to 5 years in a QA, RA department in medical device;
  • In-depth kledge of ISO 13485 is a must-have;
  • An experience in medical device related to the pharma world is a plus;
  • An experience in clinical activities for medical devices or combination products is a plus;
  • A kledge of container closure system or primary packaging would be a plus;
  • od level of English both in written and oral is mandatory;
  • od level of French both in written and spoken is a plus.