Design Quality Engineer DQE- Medical Devices

Job description

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.