Senior Quality Engineer - Manufacturing - Ayer, MA

This Senior Quality Engineer will lead quality validation, product qualification and risk management activities across the full product lifecycle. You will act as the site subject‑matter expert, partnering closely with engineering, manufacturing and R&D to ensure robust, compliant and scalable quality systems.Client DetailsOur client is a global industrial technology business operating in highly regulated markets where quality and safety are mission‑critical. They combine long‑term stability with strong investment in innovation, people development and continuous improvement.DescriptionLead and continuously improve site quality validation, qualification and risk management programmesAct as quality SME for NPI and design & development activities, ensuring compliant deliveryOwn QMS processes including procedures, templates and quality recordsDrive investigation of non‑conformances, deviations and complaints through structured root cause analysisLead CAPA activity using data‑driven problem‑solving methodologiesEnsure all design, product and process changes are risk‑assessed and compliantPartner cross‑functionally with Engineering, Manufacturing, Supply Chain and Quality teamsSupport and review verification & validation (V&V) protocols and documentationParticipate in and conduct internal audits, producing actionable audit reportsCoach, train and mentor colleagues on quality tools, systems and best practicesChampion a culture of quality, continuous improvement and risk‑based thinkingMPI 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.ProfileBachelor's degree in Engineering or a scientific discipline5+ years' experience in Quality Assurance within a regulated industryStrong working knowledge of ISO‑based quality systemsHands‑on experience with product and process validationSolid understanding of design and development lifecyclesInternal audit experience (lead auditor certification highly desirable)Proven CAPA, root cause analysis and continuous improvement capabilityConfident communicator able to influence cross‑functional stakeholdersJob OfferVisible ownership and influence across site‑wide quality strategyExposure to complex, regulated products with real‑world impactStrong investment in training, career progression and leadership developmentCollaborative, inclusive culture with genuine cross‑functional partnershipHighly competitive benefits including retirement, parental leave and time offDesired Skills and ExperienceQuality EngineeringQuality Management Systems (QMS)ISO 13485Product & Process ValidationCorrective and Preventive Action (CAPA)New Product Introduction (NPI)Risk Management / FMEARoot Cause AnalysisInternal AuditingRegulatory ComplianceMPI 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.