Job Description:

Plan, execute and control the company’s Quality Assurance system according to product specifications, quality and regulatory standards. Including identifying the technical requirements and ensuring that, the technical solutions and manufacturing processes are compliant with the quality standards.
Plan, execute, and control the company’s regulatory submissions, mainly to China according to product specifications, quality and regulatory standards.

The focus of the position is to develop, perform and lead Quality Assurance related activities and regulatory submissions, which include the following:

  • Maintaining procedures and quality management system up to date according to relevant standards for all company departments
  • Supervise, and support the quality assurance activities in all different company departments
  • Follow up on all different QA activities in the departments
  • Control / participate in the CA/PA process
  • Participate in internal and external audits
  • Plan and manage regulatory applications preparations and submissions
  • Follow up on regulatory projects

Experience:

  • Engineering graduate: B.Sc. or higher, recommended wit QA classes
  • 2 years’ experience in QC or QA in the Medical device industry
  • Knowledge in European/CE and FDA regulations, including ISO13485
  • Knowledge in risk Management according to ISO14971
  • Multitasked, independent, punctual and accurate with excellent organizational skills
  • Team oriented, collaborative, good personal relationships
  • Language: English – Native Speaker level

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