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Sr. SQE高級供應商質量工程師

柯惠醫療器材制造（上海）有限公司...

上海

  • 工作年限5-7年
  • 學歷要求本科
  • 招聘人數
  • 發布日期12-18 發布
  • 語言要求
職位信息

職位名稱： Sr. SQE高級供應商質量工程師

類別名稱：

職位描述：
SUMMARY OF POSITION:The Senior Supplier Quality Engineer (Sr. SQE) is responsible for working with and developing finished goods suppliers on QMS related matters pertaining to qualification, manufacturing, QMS development, and technical quality/service/costs improvements for outside vended products and suppliers in Asia.The Sr. SQE is a member of a team based in Asia and reports directly to the Quality Manager – Contract Manufacturing.ESSENTIAL FUNCTIONS:?As part of the Contract Manufacturing Quality team in Asia, organize, direct and report on all supplier quality-related activities for contracted designed and manufactured items made in Asia (under your control).?Conduct audits at existing and new suppliers, develop corrective action plans, and follow up with suppliers to ensure deficiencies/risks are mitigated.?Develop, implement, and monitor supplier development initiatives, including supplier performance management, supplier certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selection activities, that align with the Contract Manufacturing strategic goals and objectives.?Ensure supplier compliance with Medtronic Quality Systems and all relevant internal procedures and policies.?Facilitate customer complaints that ensures adequate investigation and corrective actions are taken by suppliers.?Manage Supplier Corrective Action Request program for assigned suppliers to ensure consistency in handling corrective actions by suppliers?Work with new and existing suppliers to develop, implement, and maintain technical quality assurance systems and activities, to include MSAs, SPC, Quality Plans, Control Plans, and FMEAs.?Develop, communicate, and manage a strategy/plan for addressing finished goods supplier capability deficiencies, etc.?Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR – Supplier Change Request) at suppliers.?Manage and report on supplier audit program in line with ISO and/or FDA 21 CFR part 820 regulations?Translate engineering, manufacturing, and quality requirements for outside vended products.?Perform deviation investigations into quality issues arising from supplier activities.?Manage qualifications of changes and co-ordinates associated change control activities.?Conducts quick and efficient assessments of potential supplier’s Quality systems, with limited information.?Work with the NPD Supplier Quality team on new projects with new suppliers and their associated quality and development plans.?Evaluate suppliers using Medtronic Supplier Quality and Supplier Performance Management processes and develop reports on supplier quality performance for company management , recommend and implement the continuous improvement of supplier quality systems?Responsible for ensuring that effective up-to-date supplier Quality Assurance documentation, procedures and specifications pertaining to Asia Contract Manufacturing quality are maintained.?Promote a culture of continuous improvement and cost reduction with existing and new suppliers.OTHER FUNCTIONS:?Participates in project teams associated with product, process or sourcing activities and improvements for outside vended products?Is the liaison between GBU and outsourced manufacturing sites for the deployment and communication of needs and new or improved quality requirements?Responsible for supplier quality activities associated to sub-tier suppliers in the event of acquisitions and divestitures of outside vended suppliers.?Evaluates purchased product performance as necessary and recommends and implements applicable improvements.?Ensures statistical process tools are used effectively to reduce waste and product variability.?Works with internal auditors on audits or inspections required to be completed on purchased product.
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