Requires a Masters degree in Mechanical, Industrial or Biomedical Engineering and two 2 years of experience in quality engineering; or Bachelors degree in Mechanical, Industrial or Biomedical Engineering and four 4 years of experience in quality engineering.br br Must possess at least two 2 years experience with the followingbr br Supplier Quality Engineering in the medical device fieldbr CAPA, Risk Mgmt. Analysis, Supplier Controls, Process Validation, Product Acceptance Sampling, Approved Supplier List, DOE, Gage RR, and GDTbr Failure investigation techniques, statistical quality control, protocol report preparation and nonconforming product controlsbr Extrusion, Injection Molding, Welding and Machining for medical devicesbr GMP in medical device environmentbr QSR 21 CFR 820, Canadian Medical Device Regulation, EU MDD 9342 EEC, JPAL and ISO 13485 and ISO 17025

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