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  • Experience with QMS Per ISO13485 / 21 CFR 820 and other country specific regulatory requirements for Med Devices
  • Good Understanding on Design control requirements.
  • As a member of product development team, represented the Quality function throughout all stages of the Product Development Process
  • Experience with Risk Management processes per ISO14971
  • Experience with Medical device manufacturing processes (including Process Validations - IQ/OQ/PQs)
  • Experience in cleanroom manufacturing process such as packaging, labelling, IFU, carton, etc.
  • Experience in handling complex projects includes multi geo, multiple cross functional teams, stakeholders etc.
  • Strong project management skill to handle multi sites
  • Project scoping, team building, project plan creation
  • Budget plan
  • Project status monitoring
  • Risk management