PMS-Complaint handling

4 weeks ago


Gurgaon, 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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