Basic Purposes & Scope主要目的和职责范围
Start-up phase:项目阶段
-Provide strong support for production line transferring, guide the process validation implementation to comply with the quality system & rent regulations，review and carry out s to reduce the risk of process validation failure 支持生产线转移，指导过程确认的实施以符合相关质量体系和法规要求，评审并采取措施以降低过程确认的失败风险
-Build up testing capacity regarding products, including setting up inspection procedures, 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，产品标准并验证测试设备
-Set up and follow up the quality control plan 建立并跟踪质量控制计划
- Take part in process validation. 参与过程确认
Build up testing capacity regarding products, including setting up inspection procedures, 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，产品标准并验证测试设备
Operate inspection procedures 执行测试程序
Train and qualify LQC 培训及考核LQC
Set up and follow up the quality control plan建立并跟踪质量控制计划
Routine production:日常生产
-Perform WIP product release, and complete quality report 实施WIP产品放行，完成质量报告
-Identify NCs and CAPAs in a systematic way, e.g. using statistical tools 系统地识别不合格和CAPA，例如，运用统计工具
-Take responsibility for quality improvement 负责质量改进
-Cooperate with other Engineers for complaint investigation and close 与其它工程师协作完成投诉处理
- 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
Cooperate with other Engineers for failure investigation, including NCR, deviation and complaint, etc与其它工程师协作完成实效调查，包括不合格、偏差和投诉
Authorize to release 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半成品和成品
Other tasks defined in QMS. QMS 定义的其他职责
Comply with Company’s EHS policies, regulations and procedures

Job Specifications职位要求
- A bachelors degree in scientific or engineering discipline.
本科学历，科学或工程背景
- Mechanical or Electrical education as a plus
机械或电子教育背景优先考虑
-Minimum 4 years experience in quality field in manufacturing environment. 至少4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
- Understand requirements of process/equipment validation
了解过程/设备确认
- 6 sigma certificate as a plus
具有6 sigma 证书优先考虑
- 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）
- Good communication skill and team spirit
良好的沟通能力和团体合作精神

Medtronic和Covidien携手合作，通过更多方式以及在全球更多地方改善医疗保健，以满足更多人的需求。作为一家公司，我们促进并增强实现有意义创新的能力。但是，要取得成功，我们的团队必须拥有优秀的人才。现在是加入我们并为改善更多人的健康作出贡献的理想时机。

通过整合Medtronic和Covidien的资源，我们具备改革能力，并创造全新方法和新机遇。不论您的专长领域或理想抱负为何，Medtronic都会让您大放光彩，让您在帮助更多人改善生活的同时拓展自己的职业生涯。

Medtronic是一家市值278亿美元的公司，它在全球超过160个国家拥有85000+名员工。

Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.