Quality Engineer

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Quality Engineer


  Bern,   Competitive

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  Engineering    Permanent

Thus is an opportunity to join a fast-growing company within the MedTech and IVD field aiding multiple project teams in the development of medical devices and in-vitro diagnostics as well as for general tasks in the area of quality management. You will be working with highly qualified engineers and scientists to develop products from idea to series production.

Responsibilities
 

  • To provide quality and regulatory support for the new and further development of medical and IVD products.
  • Ensure compliance with the quality requirements in accordance with company processes.
  • Carry out the internal audits and accompany the external audits.
  • Communicate with notified bodies and international regulatory authorities.
  • Collaboration and communication with engineers and scientists on product development matters.
     

Candidate requirements:

  • Completion of a technical or scientific university degree
  • Several years' experience within engineering.
  • Several years' experience within quality assurance.
  • Hands-on understanding of ISO 9001, ISO 13485, FDA 21 CFR part 820.
  • Understanding of national and international relevant regulations for approvals.
  • Understanding of product and device development and worked with high-risk medical devices.
  • Fluency in English and German.
 

If you, or someone you know are interested please send your CV across to .

Hannah.Hughes

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