Job Information
Danaher Corporation 供应商质量工程师（仪器）Supplier Quality Engineer (Instrument) in Suzhou, China
工作范围：
主导贝克曼库尔特实验系统苏州工厂的仪器的量产品的供应商质量管理和新品的供应商开发；
支持贝克曼库尔特集团全球合作项目的供应商供应商质量管理和开发;
主要职责：
维护、评审并实施供应商质量管理相关流程。
负责来料质量不合格品的处理，推动供应商开展原因分析及实施有效的整改。通过SCAR等方式反馈，追踪及记录。
负责供应商变更通知的及时评估和有效执行。
负责零部件来料检验指导书的制作和更新，确保其最新状态。
主导供应商年度风险评估，制定年度审核和拜访计划，并执行相关审核和拜访活动。推动供应商质量管理体系的持续改进。
主导供应商绩效的定期评估，收集、评价和报告供应商的绩效表现指标，推动供应商绩效的持续改进。
主导供应商质量协议的变更评审和签订。
在指导下，协同采购等部门开发新供应商，完成新供应商的资质评估和审核流程。
在指导下，协同供应商和Beckman跨功能小组完成新零件的开发和认可过程, 包括完成CQP, CQR ,FAIR ,Guild line和技术可行性评审；
在指导下，支持完成新项目开发/移转项目本地化的相关供应商管理和开发工作。
协助内部QA开展客户投诉和生产过程质量异常的调查。
积极主导或参与公司的持续改善活动。
完成主管分配的其他工作。
任职要求：
本科及以上学历且具备5年以上质量领域工作经验。
主修工程专业，如机械、电子等相关专业。
具备至少3年以上的在医疗器械、汽车、机械、电子等相关行业的供应商质量管理领域的工作经验。
熟悉常用的检验工具,如量具，卡尺，千分尺，投影仪，CMM等。
熟练掌握质量管理和问题解决工具，如QC七大方法、5Whys、8D、CAPA、SPC、MSA、 FMEA 、Control Plan等质量工具。
具备一定的工艺知识，如：冲压，机加工，钣金，焊接，注塑, 表面处理 , SMT等。
熟悉ISO9001, ISO13485等质量管理体系知识，至少拥有ISO9001 内审员资质。
良好的问题识别、分析和解决能力。
良好的英语读写和沟通能力。
熟练使用Microsoft 常见办公软件(i.e., excel, word, PowerPoint) 。
具有良好的团队合作能力，并有较好的沟通技巧。
良好的管理时间技巧，自我驱动和学习能力。
Scope：
Lead the supplier quality management of mass production instrument product and supplier development of new instrument product for Suzhou site of Beckman Coulter Laboratory System.
Support the supplier quality management and the new supplier development globally for Beckman Coulter Group.
Responsibility：
Maintain, review, and implement the procedure of supplier quality management.
Responsible for handling the nonconformity of the incoming material, push the supplier initiate the root cause analysis and implement the effective corrective actions. Feedback, tracking and recording the related information on the SCAR.
Responsible for the supplier change notification (SCN) on time evaluation and effective implementation.
Responsible for developing and updating the incoming inspection guild line, ensure it with the latest status.
Lead the supplier annual risk assessment work out the annual audit and visit plan, as well implement the audit, and visit activity as the schedule. Drive the supplier to continuously improve their quality management system.
Lead the supplier performance assessment periodically, collect, evaluate, and report the supplier performance KPI，drive the supplier performance continuous improvement.
Lead the supplier quality agreement change review and sign.
Under the guidance, work together with the cross-function team (such as sourcing, tech Ops etc.) to development the new supplier, complete the new supplier qualification assessment and audit process.
Under the guidance, work together with the supplier and Beckman cross function team to complete the new part/component development and approval process, including finishing the CQP, CQR, FAIR, Guild line and technical feasibility review.
Under the guidance, support to complete the supplier quality management and development for the new project development and transfer project localization.
Assist the internal QA to do the investigation for the customer complain and in-process nonconformity.
Actively lead or participate in the Kaizen activities.
Perform other tasks assigned by the supervisor.
Requirement：
Bachelor’s degree or above， with 5+ years’ experience in quality field.
Major in Engineering, such as Mechanical, electronic, etc.,
With 3+years’ experience in supplier quality management in the industry of medical device, automotive, mechanical, electronic etc.
Be familiar with the inspection tools, such as Gauge, Caliper, Micrometer, Projector, CMM etc.
Be proficient in using the quality management and problem-solving tools, such as QC 7 tools, 5Whys ,8D, CAPA, SPC, CPK, MSA, FMEA, Control plan etc.
With the knowledge of the technology and process, such as stamping, machining, sheet metal, welding, injection molding, surface treatment, SMT etc.
Be familiar with QMS knowledge of ISO9001, ISO13485and etc., minimum with ISO9001 internal auditor certificate.
Good problem identification, analysis and solving capability.
Good English skill both in written and oral.
Be familiar with the office tools including excel, word, PowerPoint etc.
Good teamwork and communication skill.
Efficient time management skills, strong self-driven and learning capability.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.