Save Job Back to Search Job Description Summary Similar JobsBe the first U.S. quality leader for FDA‑cleared implantable devicesOwn QMS, design controls, and global supplier oversight end‑to‑endAbout Our ClientThis is a fast‑growing medical device company developing advanced, patient‑specific technologies in a highly regulated space. The organization operates with a small‑team, high‑ownership mindset and is building the foundation for long‑term scale.Job DescriptionAct as the U.S. quality lead for products manufactured by overseas partnersMaintain and continuously improve the Quality Management SystemSupport design controls, design transfer, and technical documentationReview and approve batch records prior to U.S. product releaseDrive nonconformances, CAPAs, risk assessments, and design reviewsCoordinate closely with ISO 13485-certified manufacturing partnersMPI 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 ApplicantA successful Senior Quality Engineer should have:3-5 years of experience in a regulated medical device environment1-2 years of Quality Systems Engineering for implantable productsStrong knowledge of ISO 13485, design controls, and risk managementExperience supporting manufacturing transfers and supplier qualityAbility to work independently as the sole U.S. quality ownerStrong communication skills for cross‑functional and global teamsWhat's on OfferCompetitive salary ranging from $100,000 to $140,000 USD.First dedicated U.S. Quality/Regulatory hire with real ownershipBroad exposure to QMS leadership, design oversight, and suppliersHigh visibility with executive leadership and global partnersOpportunity for rapid growth in an early‑stage environmentPotential for equity participation for high performersContactCian TroyQuote job refJN-052026-7017513Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationWatertownContract TypePermanentConsultant nameCian TroyJob ReferenceJN-052026-7017513
