Quality EU MDR - W2role

Job Title: Quality Engineer IIILocation: Mansfield, MADuration: 12 Months Job SummaryThe Quality Engineer III will apply quality engineering principles to develop, maintain, and improve products and processes.This role involves ensuring compliance with EUMDR standards, managing risk, and improving manufacturing processes.The Quality Engineer will collaborate with cross-functional teams, assess supplier documentation, and drive quality improvement initiatives.Key ResponsibilitiesLead EUMDR Class II & III compliance projects.Work with suppliers to ensure process validation and compliance.Approve IQ, OQ, PQ, TMV, and Software Validations.Support quality improvement and process characterization initiatives.Conduct root cause investigations for CAPAs, nonconformances, and customer complaints.Required Skills Bachelor's degree with 5+ years of experience (or equivalent).Strong knowledge of FDA and ISO standards in product/process risk management.Proficiency in validation processes (IQ, OQ, PQ, etc.).Experience with quality improvement initiatives and supplier compliance.Strong statistical analysis and problem-solving skills.Preferred ToolsExcel, Word, PowerPoint, Outlook.