Sr. Quality Engineer II – EUMDR

Job Title : Sr. Quality Engineer II – EUMDR Compliance & Manufacturing QualityLocation: Mansfield, MADuration: 12 MonthsEmployment Type: ContractNo Benefits provided Job SummarySeeking an experienced Sr. Quality Engineer II with expertise in EU MDR compliance, Manufacturing Quality, Supplier Quality, CAPA, Nonconformance Management, and Process Validation. The role will support Class II & III medical device compliance projects, drive quality improvements, and ensure regulatory compliance across manufacturing operations.Key ResponsibilitiesLead and support EU MDR Class II & III compliance initiatives.Review supplier validations and quality documentation; execute remediation activities.Collaborate with suppliers to address Process Validation gaps.Review and approve IQ, OQ, PQ, TMV, and Software Validation activities.Drive quality improvement, process optimization, and risk management projects.Lead investigations for Nonconformances, CAPAs, Complaints, and Root Cause Analyses.Perform data analysis, trend monitoring, and process control activities.Support manufacturing operations through risk assessments and quality engineering best practices.Mentor Quality Engineers and Technicians.Required QualificationsBachelor's degree with 8+ years, Master's with 5+ years, or PhD with 3+ years of relevant experience.Strong experience in Medical Devices or other regulated manufacturing environments.Hands-on expertise with EU MDR, CAPA, Nonconformance Management, Supplier Quality, Process Validation, and Risk Management.Knowledge of FDA regulations, ISO standards, and Quality Management Systems (QMS).Experience reviewing and approving validation protocols (IQ/OQ/PQ, TMV, Software Validation).Strong analytical, problem-solving, and continuous improvement skills.PreferredMedical Device industry experience.Supplier Quality Engineering background.