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.