Save Job Back to Search Job Description Summary Similar JobsLead quality initiatives for cutting-edge medical device programsJoin a rapidly growing innovator with strong career advancement opportunitiesAbout Our ClientOur client is an industry-leading advanced manufacturing organization experiencing significant growth and investment across its operations. Known for innovation, technical excellence, and a people-focused culture, the company offers employees the opportunity to make a direct impact while working on highly complex medical technologies.Job DescriptionLead quality engineering support for product development, manufacturing, and continuous improvement projectsDrive implementation and optimization of quality systems, quality controls, and process improvementsFacilitate risk assessments and develop risk mitigation strategies using tools such as PFMEA and risk management frameworksLead root cause investigations, CAPA activities, and corrective action effectiveness reviewsSupport and execute equipment, process, and product qualification and validation activitiesDevelop and maintain quality control plans, inspection strategies, and process monitoring systemsImplement and maintain statistical process controls and sampling methodologiesEnsure compliance with ISO 13485, FDA regulations, and internal quality standardsParticipate in technical and design reviews as the quality representativeServe as a subject matter expert in multiple quality disciplinesCollaborate with customers to resolve quality concerns, complaints, and product-related issuesAuthor validation protocols, reports, process deviations, and change notificationsSupport manufacturing troubleshooting and process optimization activitiesDevelop, implement, and maintain metrology equipment and measurement systemsConduct Gage R&R studies and analyze manufacturing and validation dataApprove nonconformance dispositions and manage quality documentationDevelop quality procedures and provide training across the organizationSupport supplier quality activities, including audits and qualification effortsAct as the quality lead on cross-functional new product introduction and acceleration programsMPI 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 related technical disciplineMinimum 2+ years of Quality Engineering experience within medical device manufacturing or a regulated engineering environmentStrong knowledge of ISO 13485 and FDA 21 CFR 820 quality system requirementsExperience with CAPA, nonconformances, root cause investigations, and risk management processesKnowledge of validation and qualification methodologies for equipment, products, and manufacturing processesExperience developing quality documentation, procedures, protocols, and reportsWorking knowledge of statistical analysis tools and MinitabStrong technical writing and communication skillsAbility to interact professionally with customers, suppliers, and cross-functional teamsExperience with SPC, inspection planning, and quality control methodologiesExposure to supplier quality management and auditing is preferredCQE, Six Sigma Green Belt, or Belt certifications are highly desirableExperience mentoring team members and leading projects is a plusWhat's on OfferPermanent position.Salary range of $80,000 to $103,000.Work on innovative technologies that directly impact the medical device industryJoin a rapidly expanding organization with strong growth opportunitiesGain exposure to advanced manufacturing and cutting-edge engineering projectsTake ownership of high-visibility quality initiatives and strategic programsCollaborate with talented technical teams in a fast-paced, innovation-driven environmentContactKyle PerryQuote job refJN-102026-7131195Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingWhereBethelContract TypePermanentConsultant nameKyle PerryJob ReferenceJN-102026-7131195
