Accessibility Links

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

Similar jobs
Senior Test Engineer (IEC 60601)
  • Job type: Permanent
  • Location: Gothenburg
  • Salary: Competitive
  • Description Senior Test Engineer (IEC 60601) - Medical Device Company - Sweden - Gothenburg My client is looking for Senior Test Engineer based near Gothenburg -
QA Manager - Medical Device
  • Job type: Permanent
  • Location: Windsor
  • Salary: $90000 - $130000 per annum
  • Description QUALITY ASSURANCE MANAGER - MEDICAL DEVICE  MEDICAL DEVICE COMPANYWindsor, CT$90,000 - $130,000 + Bonus +
Sales Representative Cologne
  • Job type: Permanent
  • Location: Cologne
  • Salary: Competitive
  • Description Sales Representative Cologne A mid-sized and incredibly exciting Medical Devices company is seeking an experienced Sales person to be based in or around Cologne, in...
Director of Regulatory Affairs and Quality Manager
  • Job type: Permanent
  • Location: Basel
  • Salary: Competitive
  • Description A leading multi-national Medical Device company is seeking an experienced Quality or Regulatory Manager required to direct their Basel office. The Quality & Regulatory Director...
Quality Manager Qualified Person
  • Job type: Permanent
  • Location: Amsterdam
  • Salary: Competitive
  • Description Quality Manager Qualified Person  Where are you going to work? My client is a global pharmaceutical company who dedicate their R&D to lead innovation in...