Design Quality Engineer DQE- Medical Devices

Bachelor’s Engineering degree with related 5-7 years of experience in -Mechanical/ Electrical/ Electronic or Equivalent Engineering (medical device or regulated industries preferably)

✓ Hands on experience in problem solving technique
✓ Working knowledge of appropriate global regulations, requirements, and standards.
✓ Understand Statistical Methods , Safety Risk Management (i.e ISO 14971) and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis
✓ Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)
✓ Performs independent technical assessment on design changes &product quality
✓ Independently produces and completes Quality Engineering Documents
✓ Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer BOMCheck and strong expertise in Windchill, product BOM structures, and compliance areas like REACH/ROHS, AGEC, and SCIP.
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