Senior Quality Engineer - Medical Device - Hopkinton, RI

Job TitleDrive product and process quality using statistical tools, audits, and structured problem-solving methodologiesLead and maintain process validations, including PFMEAs, OQ/PQ, PPAPs, FAIRs, and validation reportsManage MRB activities, NCRs, and CAPA, ensuring effective corrective actions and follow-upAnalyse manufacturing and validation data to reduce variation, waste, and defectsReview and control internal and external changes, including customer specificationsSupport ERP-related activities including route and BOM approvalsLead and support software validation activities, including test cases and validation documentationInvestigate customer complaints using structured root cause analysis techniquesSupport internal, customer, and registrar audits as requiredAbout Our ClientThis organisation is a well-established manufacturer operating in a highly regulated industry, known for its technical complexity and commitment to quality. The culture values collaboration, accountability, and people who enjoy making tangible improvements in how products are built and validated.The Successful ApplicantBachelor's degree in Engineering or a related technical/scientific discipline1-3 years' experience in a medical device manufacturing environmentStrong working knowledge of ISO 13485:2016 and familiarity with FDA CFR Part 820Hands-on experience with process, product, and software validationStrong analytical skills; experience with statistical tools (Minitab preferred)Experience with ERP systems and a fast-paced manufacturing environmentExcellent written and verbal communication skillsWhat's on OfferHigh-impact role with real ownership of quality and validation activitiesExposure across engineering, manufacturing, and operationsOpportunity to strengthen regulated industry expertiseStrong emphasis on continuous improvement and best practicesStable environment with long-term growth potentialJob SummarySector: Engineering & ManufacturingSub Sector: Quality, TechnicalIndustry: Healthcare / PharmaceuticalWhere: InternationalContract Type: PermanentConsultant name: Taylor RankinJob Reference: JN-052026-7028979