Job Details: Senior Global Supplier Quality EngineerFull details of the job.Job Requisition Name Senior Global Supplier Quality EngineerJob Requisition No VN8400Work Location Name Italy - RemoteWorker Basis Full TimeWorker Type EmployeeContract Type PermanentApplications Close DateKey Responsibilities
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Lead qualification, performance monitoring, and lifecycle management of critical global suppliers in collaboration with cross-functional stakeholdersProvide expert technical oversight during supplier process development, scale-up, validation, and production transferConduct deep technical reviews of supplier processes including PFMEA, control plans, validation protocols, and capability studiesLead complex cross-site root cause investigations (CAPA, NC, SCAR) using advanced engineering methodologies and ensure effective corrective actionsDefine and execute global supplier quality strategies aligned with business objectives, technology roadmaps, and risk-based sourcing plansRepresent Supplier Quality in global NPD projects, ensuring Design for Manufacture, Design for Assembly, and supplier readinessLead supplier audits and drive sustainable quality improvement plans across global supplier networksAssess and manage supplier-initiated changes and internal changes impacting supplier processesPrepare and present quality performance summaries to senior leadership and support customer and regulatory auditsDevelop and maintain quality and purchasing specifications to ensure consistent implementation across suppliers
Qualification
Bachelor's degree in Engineering, Science, or related discipline10 years of experience in Quality Engineering or Supplier Quality within the medical device or pharmaceutical industryCertified Lead Auditor to ISO 13485Strong knowledge of manufacturing technologies such as precision machining, injection molding, laser processing, coatings, electronics assembly, and component manufacturingAdvanced ability to interpret engineering xlwpduy drawings, GD&T;, tolerance analysis, and material specificationsDeep understanding of global regulatory frameworks (FDA QMSR/QSR, ISO 13485, ISO 14971, EU MDR, MDSAP)Proven ability to influence senior stakeholders through data-driven recommendations and technical expertiseAbility to navigate ambiguity and drive decisions in fast-paced, global environmentsAvailability to travel 30–50% of the time, depending on the month and project scope, including travel to Mexico and the United StatesFlexibility to accommodate occasional work across Mexico and US time zones, particularly during audits and critical project phases
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