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Quality Assurance & Validation Consultant-Medical Devices f/m

Altran AG

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Quality Assurance & Validation Consultant-Medical Devices f/m

 Area of Responsibility:

  • Initiating improvements of Quality Management System compliance
  • Ensuring Regulatory requirements to MDD 93/42/EEC.
  • Ensuring consistent implementation of the QMS processes.
  • Performing the review and approval of Design Control Documents, SOPs 
  • Assisting in Risk Management activities: FMEA and Reliability studies 
  • Handling of Change Requests, Non Conformities and CAPAs
  • Planning and execution of Verification & Validation activities. 

Your Profile:

  • Master in Biomedical or Mechanical Engineering (ETH/TU/TH/FH)
  • At least 3 years of experience in Quality Assurance in MedTech.
  • Excellent knowledge of European and US regulations, procedures, standards 
  • Excellent knowledge of guidelines (MDD, QSR, ISO 13485, ISO 14971)
  • Very good IT skills (Sharepoint, MS Project, Excel)
  • You are capable to deliver on time and with high quality
  • You speak German fluently, possess excellent writing skills in English
  • You are mobile for projects in the German part of Switzerland