PMS-Complaint handling

Found in: Appcast Linkedin IN C2 - 2 weeks ago


Gurugram, India ALTEN Full time

Experience & Skills

  • BE/BTech, ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
  • 2-6 years of experience in Medical Device domain preferred
  • At least 2+ years of experience in complaint handling or customer quality.
  • Understanding of Post Market Surveillance requirement of Medical Devices under FDA & EU MDR regulations
  • Understanding on Medical Device Risk Management
  • Hands-on Experience on Complaint handling and Product investigations of medical devices.
  • Experience on root cause analysis of field returned products.
  • Understanding on NC CAPA process.
  • Knowledge of various quality tools.

Tools -

  • TrackWise complaint handling tool or equivalent
  • Microsoft office Word & Excel


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