Save Job Back to Search Job Description Summary Similar JobsHands‑on ownership across production, CAPA, and facility transfersHigh‑impact role stabilizing and strengthening a medical device QMSAbout Our ClientThis organization is a growing, regulated manufacturer focused on delivering high‑quality products that directly impact patient outcomes. They offer a collaborative, operations‑driven culture where quality has a true seat at the table and engineers are empowered to make change.Job DescriptionSupport production quality activities including in‑process inspection, final release, and lot history record reviewLead Material Review Board (MRB) activities and disposition of nonconforming materialDrive timely product release to meet customer delivery and operational commitmentsInterface with customers and suppliers to resolve quality issues and drive corrective actionsLead and support CAPA, complaint investigations, and root‑cause analysis activitiesMaintain compliance with ISO 13485 and FDA 21 CFR Part 820 requirementsSupport internal, customer, and regulatory audit readiness and executionProvide quality leadership during facility transfers, line moves, and manufacturing transitionsPartner with Operations, Engineering, and Validation teams on IQ/OQ/PQ and revalidation effortsMonitor quality metrics, SPC data, and trends; communicate insights to site leadershipMPI 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 technical discipline (or equivalent experience)5+ years of experience in medical device manufacturing qualityStrong working knowledge of ISO 13485, FDA 21 CFR Part 820, and ISO 14971Proven experience leading CAPA, investigations, and audit readiness initiativesExperience supporting facility transfers, equipment moves, or manufacturing transitions strongly preferredHands‑on mindset with the ability to balance floor support and system‑level quality oversightWhat's on OfferVisible, high‑ownership role with real operational impactExposure to complex quality challenges in a regulated environmentOpportunity to lead quality efforts during critical site and process transitionsStrong cross‑functional collaboration with Operations, Engineering, and LeadershipStable organization that values quality, accountability, and continuous improvementContactJenny LyQuote job refJN-062026-7031804Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationTauntonContract TypePermanentConsultant nameJenny LyJob ReferenceJN-062026-7031804
