Senior Quality Engineer - Manufacturing - Littleton, MA

Own site‑wide quality strategy and validation for complex productsHigh‑visibility role influencing NPI, risk, and regulatory complianceAbout Our ClientThis global manufacturing organization is part of a highly respected engineering group known for innovation, stability, and long‑term investment in its people. The business offers a collaborative culture, strong quality mindset, and exposure to technically complex products used in regulated industries.Job DescriptionLead and maintain site quality validation, product qualification, and risk management programs aligned to ISO and internal QMS standardsProvide quality engineering leadership to New Product Introduction (NPI) and design & development activitiesEnsure effective verification and validation (V&V) of products and processes throughout the development lifecycleDrive investigation of nonconformities, deviations, and customer complaints using structured problem‑solving methodologiesLead and support CAPA activities through robust root cause analysis and data‑driven decision makingOversee change management activities, ensuring all quality impacts are assessed, documented, and implemented correctlySupport and participate in internal audits, generating findings and driving continuous improvementCoach, train, and mentor cross‑functional teams on quality tools, systems, and best practicesPromote a strong culture of quality, risk‑based thinking, and continuous improvement across the siteMPI 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 or a scientific discipline5+ years of experience in Quality Engineering or Quality Assurance within a regulated manufacturing environmentStrong working knowledge of ISO 13485 and ISO 9001 standardsProven experience with product and process validation methodologiesAdvanced problem‑solving skills, including CAPA, root cause analysis, and risk management toolsWhat's On OfferHigh‑impact position with ownership over site quality and validation strategyExposure to technically advanced products in regulated industriesStrong cross‑functional influence and leadership visibilityExcellent benefits, work‑life balance, and people‑first cultureBacking of a stable, global engineering group with long‑term growthContact: Emma WhiteQuote job ref: JN-052026-7018438