3 days ago on jobs.ch

Risk Manager FMEA - Medical Devices f/m

Altran AG

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Risk Manager FMEA - Medical Devices f/m

 Area of Responsibility:

  • Risk Analyses according ISO 14971 for Medical Devices and Combination products
  • FMEAs (Design, System, Process, Application)
  • Description and implementation of a revised Risk Management SOP according to ISO 14971
  • Implementation of a suitable risk policy in conjunction with Product Management
  • Moderation of System/Design-FMEAs and Risk Analyses for Medical Devices
  • Creation of appropriate reports and priorization of risks/failures during development phase
  • Collaboration to implement ISO requirements in quality management system

Your Profile:

  • Master in Pharmaceutical or Chemical Engineering, Pharmacy, Chemistry ETH/TU/TH/FH
  • At least 3 years of experience in Quality Assurance, Manufacturing, Engineering or Quality Control 
  • Demonstrated knowledge of European and US regulations, guidelines and standards (GMPs, FDA,…)
  • Multiple years of experience in determining health-hazards and health-risks of Medical Devices
  • Experience in coordination and implementation of products recalls 
  • Experience in CAPA planning activities, quality review, assessment of CAPA closure activities
  • You speak fluently English and are capable to deliver on time and with high quality
  • You are mobile for projects in the German part of Switzerland