Design Quality Engineer - Medical Devices

Bachelors 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. .