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Quality Engineer (CAPA)

  • Job type: Permanent
  • Location: Göttingen
  • Salary: Competitive
  • Job reference: 125
  • Sector: EPM Scientific, Quality
  • Date posted: 01/12/2017
You can look forward to that
  • Introduction of a DIN EN ISO 13485: 2016 and US FDA Quality System Regulation (21 CFR 820) compliant system for corrective and preventive actions as well as non-conformities
  • Implementation of corrective and preventive measures as well as non-conformities according to DIN EN ISO 13485: 2016 and US FDA Quality System Regulation (21 CFR 820)
  • Moderation and support in the preparation of risk analyzes
  • Support of the departments in quality management tasks
  • Maintaining and continuously improving the quality management system
Your skills
  • Successfully completed technical or scientific studies
  • Several years of experience in quality management in the field of medical products/pharmaceuticals
  • High technical understanding of the development and production of medical devices
  • Very good knowledge of DIN EN ISO 13485: 2016 and US FDA Quality System Regulation (21 CFR 820) as well as DIN EN ISO 14971
  • Strong knowledge of regulatory requirements in the development and manufacture of medical devices in Europe and the US
  • very good knowledge of English
  • Goal-oriented and structured way of working
  • Open-mindedness and strong communication skills
If of interest, please contact me on: Vithusa Uthayakumar 
                                                     +44 203 873 2541 
                                                     vithusa.uthayakumar@epmscientific.com

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