Senior QA/RA Expert (ID1004)

100,00 kr.

Eva Steinick
Umeå university, Lund university


  • Project management.
  • Quality management.
  • Management Representative.
  • Gap Analyses.
  • Quality systems implementation.
  • Design Control.
  • Design Dossiers and Technical File forCE marking.
  • Preparation and submission of int.l registrations for Class IIa, IIb and Class III medical devices and for IVDs.
  • Trained Lead auditor; supplier audits, internal audits.
  • Risk Management, Complaints, CAPAs.
  • Software Validation.
  • Change Control.
  • Vigilance.
  • FSCAs.
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