Sr. Quality Engineer
Oxenham Group - holbrook, MA
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Sr. Quality Engineer Hybrid in Mansfield, MA 1 year contract with opportunity to convert full time Senior Quality Engineer for EUMDR Class II & III Compliance Projects. Works in a cross-functional team to assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required remediation activities. Works with supplier base to identify gaps to EUMDR requirements, specifically related to Process Validation. Prepares Progress Reports and Metrics for review by Sr. Management. Requirements : Minimum 5+ years of experience leading Process Validation activities with external suppliers. Strong Quality and Process Validation skills and experience (IQ, OQ, PQ, PVE). Working knowledge of Medical Device Regulations and International Standards including Directive 93/42/EEC and ISO 14971.2019 and proven experience with EU Medical Device Regulation 2017/745, US FDA 21 CFR 820, and ISO 13485:2016 required Bachelor's degree in a scientific discipline, preferably engineering. Strong knowledge of EUMDR regulations
Created: 2024-10-08