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Bengaluru Area, India, haryana India

Q&R, Complaint Investigator at Philips

 Trained Clinical Engineer  New Product Development Process  Design Controls Implementation as per QSRs (21 CFR 820); ISO 13485  Compliance with FDA, MDD guidelines, cGMP, GDP  Risk Management, ISO14971, DFMEA, UFMEA, Hazard Analysis  Orthopedics, Spinal, Urological, IVF and Drug delivery devices  CHU - Complaints Investigation & Analysis, Reliability Analysis, PMS, Regulatory reporting  Design Verification & Validation activities  Development of Design History File, Technical file, Design Reviews