Manufacture Engineer (in 医疗器械无菌室） 苏州

月薪： 1-1.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 免费班车
  • 员工旅游
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 专业培训
  • 出国机会
  • 绩效奖金
  • 年终奖金

职位描述

职位描述： Title: Manufacture Engineer (In Clean room)Report to: Production & Engineering ManagerJob Summary:     You are as manufacture engineer when transferring new project from oversea. You will be responsible for production & engineering for the new sterilize product from NPI to mass production.      在新项目转移过程中，作为无菌产品的制造工程师，负责项目从NPI到量产过程中的生产制造技术方面。Responsibilities/岗位职责:1.As the key role of NPI project team to handle manufacture engineering related work such as technical evaluation, transform design input…作为NPI项目团队的关键成员负责制造工程相关的事宜 ，如技术评估及设计输入转化。2.Develop new process, define layout out &VSM,负责开发新的工艺流程；设计新产线布局和价值流图。3.Select equipment based on drawing/Spec requirement as well as design fixtures/tooling/jigs and setup new production line。根据图纸和标准的要求确定设备的选型以及设计相应的工具治具和工装。4.Coordinate the related facility activities such as water/power/vacuum air/IT, etc. to support the new production line.协调新产线需要的水电气IT等方面相关的厂务和设施工作。5.Prepare qualification/validation documents (Validation Plan, IQ,OQ, PQ、PFEMA、WI/DHR), complete PV and complete qualification and validation reports.负责编写新生产线相关的文档（验证计划，IQ/OQPQ，PFMEA，WI/DHR）,执行新产品的过程验证并形成报告。6.Participant and ensure the related QMS & GMP regulatory will be well executed in clean room.参与并确保相应的质量体系和GMP规范在无菌车间内的实施与执行7.Contact with supplier for related project issues, including cooperate with supplier to contact with tooling plant for tool modification and improvement.协调一些供应商原材料问题，与供应商一起改善原材料质量。8.Continuously improve the performance of cell in clean room (Quality, Delivery, Cost)对无菌车间的量产生产线的关键指标（Q，D，C）的持续改善9.Maintain part number and BOM, routing in ERP system (SAP).ERP系统内对主数据，BOM,及工时的维护。10.Implement ECR & ECN for product changes and coordinate with related department to make it smoothly.完成相应的工程变更11.Prepare documents for audits from FDA, CFDA and TUV….为了FDA，CFDA及TUV等机构的审核准备相关文件12.technical training for team member培训团队成员相关知识支持13.Complete any other duties as assigned by manager其它上司安排的工作任务Requirements/岗位要求:1.Bachelor or equivalent Degree, At least 3 years working experience to work in a Medical company or have the experience to handle with Medical programs;本科以上学历，至少3年医疗相关的工作经历2.Above CET-4,Multi-national English-speaking company is preferred, need to communicate freely with foreign engineer.英语四级以上，听说读写流利，可以无障碍与国外技术人员沟通交流。3.Has the experience of cleaning room and consumables production is preferred.有洁净室和耗材的生产经验更佳。4.Have the process knowledge, assemble, molding, machining etc., fixture design and UV glue dispensing & curing experience is preferred具备常见工艺知识如装配，注塑，机加工等，有工装设计经验和UV胶喷涂固化工艺知识更佳。5.Able to design and set up new production line and continue to improve it.能够设计和搭建新项目生产装配线并对其不断优化。6.Strong problem solving skill, master finish bone, 5 shy, problem solving related tools, 6 sigma experience is preferred.能够快速分析问题解决问题，会使用常见问题的分析工具，有六西格玛经验更佳7.Have the experience of quality tool, such as SPC, MSA, PFMEA etc.了解常用的质量工具，如SPC, PFMEA, MSA等。8.Good knowledge and experience in lean manufacture有相关精益生产的经验 职能类别： 医疗器械生产/质量管理 产品工艺/制程工程师

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公司信息

汇杰是一家专业国际招聘咨询服务公司，致力于为企业提供中高级专业人才的招聘解决方案。汇杰咨询在2004年创办于苏州，现在已经成长为中国长三角地区最专业的人才服务机构之一。 汇杰扎根于中高端人才的招募，专注于工业制造、能源化工、医药医疗、消费品、教育、现代服务业、通用职位等行业的招聘。 我们的招聘领域包含：高层管理、工程与运营、人力资源、信息技术、市场营销、供应链、财务等领域。每个岗位职能又可以按照行业细分到更深层次的不同职能。

苏州相关职位

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苏州相关职位： 客服经理 医药代表/学术推广专员（辉瑞欣母沛 - 苏州） Asia RA Manager Manufacture Engineer 注册专员 Senior Manager,Drug Production of GMP Pilot Plant 质量工程师 网络销售经理 临床监查员CRA 工艺技术员

周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南

企业入驻日期： 2017-11-09

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