full time tech

Job Details

Insight Global is looking for a Senior Quality Engineer for one of our largest medical device clients to support EUMDR. This candidate specifically will support their specialty surgeries division to lead EUMDR Class 2 and 3 compliance projects. They will work in a cross-functional team to assess Supplier Validations for compliance to EUMDR requirements and perform gap assessments, specifically related to Process Validation as well as prepare Progress Reports and Metrics for review by Sr. Management. Finally they will supervise and oversee supplier quality engineers supporting this audit compliance project. Minimum RequirementsBachelors degree in a scientific discipline, preferably engineering10+ Years Experience in a highly regulated industry Working knowledge of Medical Device Regulations and International Standards such as European Good Manufacturing Practices including Directive 93/42/EEC, as amended, EU Medical Device Regulation 2017/745 and US FDA 21 CFR 820, ISO 13485:2016... required Strong Supplier Quality and Process Validation Skills (IQ, OQ, PQ, PVE) and Experience essential to success in this role Desired SkillsEUMDR experience

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