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Quality Manager - Medical Device - West Boylston, MA

Own end‑to‑end quality strategy in a regulated medical environmentLead, influence, and elevate quality across the entire organizationAbout Our ClientThis is a growing, technically focused manufacturing organization operating in a regulated environment where quality is central to the business. The company offers strong leadership visibility, hands‑on influence, and the opportunity to shape quality systems as the business continues to evolve.Job DescriptionOwn and continuously improve the Quality Management System in line with ISO 9001:2015 and ISO 13485 standardsServe as Management Representative, reporting directly to senior leadership on quality performance and complianceLead internal audits, CAPA, management reviews, and customer complaint handlingPartner with manufacturing and engineering teams to implement new testing criteria, assembly methods, and process improvementsEstablish and maintain product, process, and raw material quality standards across productionOversee supplier quality, including qualification, performance, and corrective actionsSupport new and transferred projects using APQP, PPAP, and IQ/OQ/PQ methodologiesLead and develop the Quality team through training, coaching, and performance managementMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Successful ApplicantBachelor's degree with 5+ years of quality experience in a manufacturing environmentStrong working knowledge of ISO 9001 and ISO 13485 standardsExperience in medical device or highly regulated manufacturing environmentsHands‑on expertise with SPC tools, metrology equipment, and GD&TProven leadership experience managing and developing quality teamsWhat's On OfferSenior, visible role with ownership of site‑wide quality strategyOpportunity to lead and shape quality systems in a regulated environmentStrong cross‑functional influence across manufacturing, engineering, and leadershipHands‑on technical role with real decision‑making authorityStable business with long‑term growth and continuous improvement focusContact: Emma WhiteQuote job ref: JN-052026-7018461