Save Job Back to Search Job Description Summary Similar JobsLead high-impact QMS improvements in a fast-paced med device site.Own facility transfers & drive real operational transformation.About Our ClientThis organization is a growing, innovation-driven manufacturer operating in a highly regulated industry, committed to delivering high-quality products that impact lives. They offer a collaborative, fast-moving environment where quality professionals can make visible, meaningful contributions to operational excellence.Job DescriptionSupport day-to-day production quality, including inspections, batch release, and documentation reviewLead Material Review Board (MRB) processes and manage nonconforming product dispositionCollaborate with suppliers and customers to resolve quality issues and drive improvementsMonitor supplier performance and oversee corrective actions and material qualityConduct complaint investigations and analyze returned products for root causeEnsure compliance with ISO 13485 and FDA 21 CFR Part 820 requirementsSupport audit readiness and participate in internal and external quality auditsLead CAPA activities, including investigations, root cause analysis, and corrective actionsMaintain and improve risk management processes, including PFMEAs and control plansManage change control processes and cross-functional impact assessmentsProvide quality oversight for facility transfers, including equipment moves and re-validationPartner with engineering and operations on process re-qualification (IQ/OQ/PQ)Update quality documentation, inspection plans, and risk assessments during transitionsAnalyze quality metrics and deliver insights to leadershipImplement and sustain SPC, data analysis, and process control improvementsMPI 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.MPI 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 in Engineering, Life Sciences, or related field (or equivalent experience)5+ years in medical device manufacturing quality rolesStrong experience with ISO 13485, FDA 21 CFR Part 820, and ISO 14971Proven track record in CAPA, root cause analysis, and audit readinessExperience supporting production environments with urgency and accountabilityPrior exposure to facility transfers, line moves, or site transitions preferredStrong analytical skills with experience in SPC, MSA, and statistical tools (Minitab ideal)Excellent communication and cross-functional collaboration abilitiesASQ certification (CQE, CQA, or CQM) is a plusWhat's on OfferHigh-visibility role with direct impact on operations and quality systemsOpportunity to lead facility transfer and transformation initiativesWork in a regulated industry with strong career growth potentialCollaborative, cross-functional environment with hands-on involvementCompetitive environment for developing advanced quality engineering expertiseContactTaylor RankinQuote job refJN-062026-7037404Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationRaynhamContract TypePermanentConsultant nameTaylor RankinJob ReferenceJN-062026-7037404
