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Dreem // neurotechnology
Engineering, Internship    Paris, le-de-France, France    Posted: Tuesday, July 23, 2019
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The main mission of the role involves supporting the team during the set-up of the companys Quality Management System, in compliance with the main medical device regulations such as ISO 13485:2016 & FDA Quality System Regulation.

This consists of:

  • Preparation of Quality Management System documentation: Procedures, Working Instructions & Modules.
  • Support in the definition of the companys internal processes (such as supplier management, training, change control) & the preparation of related documentation.
  • Management of key quality processes such as Customer Complaints, Validation actives & CAPA.
  • Ensuring that electronic documents are managed according to the internal process & applicable regulatory standards.
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