上海招聘

JOB RESPONSIBILITIES

工作职责

• Start-up phase: 项目阶段

  • Build up testing capacity regarding products, including setting up inspection procedures, material/product specifications and qualify testing equipment. 建立和产品相关的测试能力，包括建立测试程序，材料/产品标准并验证测试设备

  • Take part in process validation. 参与过程确认

  • Operate inspection procedures 执行测试程序

• Routine production: 日常生产

  • Perform batch record review to develop quality metric and drive defect reduction effort. 实施批记录审阅，建立质量指标并驱动降低不良

  • Perform statistical analysis of process data; interpret, compile and organize results. 实施过程数据的统计分析，解析并编辑组织

  • Address product quality issues and organize quality improvement 识别质量问题，组织质量改进

  • Authorize to release material, in-process product & FG(If they meet the pre-defined spec) relating to his/her responsible product line. 授权放行与其责任产品相关材料、半成品和成品

  • Complaint investigation  完成投诉调查研究

• Develop team ability 开发团队能力

• As the knowledge source of QE 可作为QE的知识来源指导QE工作

• As a knowledge source to guide other QEs 作为知识源指导其他QE

• Other tasks defined in QMS. QMS 定义的其他职责

  
  

WORK ENVIRONMENT

工作环境

- Base in Shanghai Plant 上海工厂

  

JOB QUALIFICATIONS

岗位资质 

1. Knowledge / Education 教育背景

- A bachelor’s degree in scientific or engineering discipline.

本科学历，科学或工程背景

- Mechanical or Electrical education background as a plus

机械或电子教育背景优先考虑 

2. Job Experience 工作经验

-Minimum 7 years experience in quality field in manufacturing environment. 至少7年生产质量经验

-Experience in medical device and/or knowledge of a wide range of manufacturing technologies is desired. 医疗器械知识，通晓生产技术

- Experience in sterile device manufacturing as a plus

无菌器械生产优先考虑

3. Skills / Competencies 技术能力

- Understand requirements of process/equipment validation

了解过程/设备确认

4. Credential 证书

- 6 sigma certificate as a plus

具有6 sigma 证书优先考虑

5. Language / Computer 语言/ 计算机能力

- Fluent verbal and written English 流利的读写英语

- Good computer skill of Microsoft application software计算机操作（微软应用程序）

6. Others 其他

- Good communication skill and team spirit

良好的沟通能力和团体合作精神

柯惠医疗器材制造（上海）有限公司即美敦力上海工厂（SMF）是美敦力在华独资的***家生产企业，成立于2006年11月，于2007年4月正式启用。公司坐落于漕河泾高科技园区，总投资4000万美金，总建筑面积达18，414平方米。其中10万级洁净车间面积为3000平方米，实验室总面积为500平方米。公司员工总数近340名，现生产产品16个品种，包括心脏瓣膜、医用高频仪器设备，腹部外科手术器械，手术室、急救室、诊疗设备及器具。
Medtronic Shanghai Manufacturing Facility (SMF) is Medtronic’s first wholly-owned manufacturing subsidiary in China. The site was founded in November 2006 and officially inaugurated in April 2007. With an initial investment of 40 million USD, SMF boasts a gross floor area of 18,414 square meters in Caohejing Hi-Tech Park. The site is composed of 3,000 square meters with Class-8 clean room and 500 square meters for laboratory use. There are currently 340 employees and 16 product lines producing
tissue heart valves, high-frequency medical equipment, abdominal surgery instruments, and diagnostic/treatment instruments used in the operation room and first aid.

公司每年平均引入1-2种新产品投入生产。2014-2015年与美敦力中国研发联手，成功推出基于微波消融技术的肝癌手术设备和新一代血管闭合与组织融合先进电外科设备。2016年公司更以1300万美元的投资额引入美敦力全球***的事业部-心脏业务集团的心脏瓣膜项目，以造福先天性心脏病、风湿性心脏病、冠心病、
心律失常或瓣膜退化、以及心脏血管病变等患者。2017年公司开始正式生产心脏瓣膜产品，预计每年将能够帮助中国和全球的65000名患者更及时地获得高品质的治疗。
SMF continuously expands its local manufacturing capabilities by adding one or two new products to its portfolio per year in average. In 2014 through 2015, collaboration between SMF and Medtronic China Technical Center successfully drove launches of the ablation technology based hepatic surgery devices and new generation of advanced electrosurgical instruments for vessel sealing and dividing. In 2016, 13 million USD was invested in SMF’s further evolvement to introduce the new tissue heart valve manufacturing line for the Medtronic Cardiac Vascular Group. The tissue heart valve material will contribute to helping patients who suffer from congenital, cardiovascular, coronary and rheumatic heart diseases. Starting 2017, the combination of our local and global heart valve manufacturing will help 65,000 patients improve their access to high-quality treatment in China and around the world.

美敦力上海工厂(SMF)致力于成为全球共享制造基地及区域性业务战略伙伴，提供世界一流品质的产品和服务，坚持人才培养，实现员工价值。
The Medtronic Shanghai Manufacturing Facility (SMF) is dedicated to becoming the global shared manufacturing site and regional business strategic partner that provides world class quality products and services, investing in talent development and realizing individual value for our employees.