Manufacturing quality engineering

Quality EngineerThis role supports the company's global product portfolio by maintaining registration status throughout product lifecycles, championing key functions of the Quality Management System, and executing supplier qualification and performance activities. The Quality Engineer serves as a liaison between internal teams, external customers, and suppliers — building strong relationships and ensuring quality standards are upheld across all areas of responsibility.Key ResponsibilitiesRisk AnalysisOversee the risk management process per ISO 14971, including review and approval of risk management files for new product development and ongoing maintenance for post-commercialization products and acquisitionsApply quality tools such as cause and effect diagrams, flowcharts, Pareto charts, and root cause analysis methodologiesReview and approve design control, manufacturing, quality, engineering, and validation documentation for conformance to procedures and risk management requirementsReview product labeling for technical accuracy, alignment with the device risk profile, and compliance with US and international regulatory standardsQMS MaintenanceReview sterilization records including monitoring logs, acceptance activity records, and sterilization certifications to verify operational and performance parametersEvaluate engineering change orders and collaborate with cross-functional teams to assess and manage changes that could impact quality riskActively participate in formal design reviews and design transfer activities to ensure adherence to product development processes and design control proceduresSupport the preventative maintenance and calibration program, including management of the master validation plan for products and softwareMaintain and remediate technical documentation to current state-of-the-art standards as requiredAnalyze quality data and provide practical, compliant guidance in support of regulatory activities, agency responses, quality KPIs, and improvement initiativesParticipate in internal and external audits and regulatory inspections across global sitesProcess Specifications & ValidationsMaintain process specifications and sterilization validations with contract sterilizers, including periodic reviews, revalidations, and product testingSupport software validations, maintenance activities, and requalification effortsDevelop product specifications, inspection plans, and test methods aligned with procedural and contract manufacturing requirements including ANSI sampling methodologyDevelop laboratory test procedures and oversee or execute test method validation and testing activitiesCAPA & NonconformanceIdentify and escalate opportunities for corrective and preventive action; support investigation, resolution, and effectiveness confirmationManage quality complaint investigations and resolve CAPAs within areas of responsibilityOversee technical sample reviews for complaint and nonconforming product samplesSupplier QualitySupport the supplier quality program including supplier validation, verification, qualification, and ongoing performance monitoringServe as the primary organizational contact for specific supplier projects and initiativesTroubleshoot technical issues related to design, development, and manufacturing in support of complaints, CAPAs, and supplier corrective action requestsDevelop and manage qualifications of specific products with new or existing suppliersQualificationsRequired:Bachelor's degree required; degree in Engineering strongly preferredPrior experience in the medical device industryWorking knowledge of ISO 13485 and 21 CFR 820Strong analytical, problem-solving, and technical writing skillsExperience with statistical analysis and associated software toolsAbility to work independently and as part of a cross-functional teamStrong project management and organizational capabilitiesPreferred:Certified Quality Engineer (CQE) and/or Certified Reliability Engineer (CRE)Lean Six Sigma Green Belt or Black BeltCertified Project ManagerKnowledge of terminal sterilization processes (EO, Gamma, I-Beam) including validation methodologiesEqual Opportunity StatementThis employer is committed to building a diverse and inclusive team. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law.