PMS-Complaint handling
Description:
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