Basic Purposes & Scope主要目的和職責(zé)范圍
Start-up phase:項(xiàng)目階段
-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 支持生產(chǎn)線轉(zhuǎn)移，指導(dǎo)過程確認(rèn)的實(shí)施以符合相關(guān)質(zhì)量體系和法規(guī)要求，評審并采取措施以降低過程確認(rèn)的失敗風(fēng)險(xiǎn)
-Build up testing capacity regarding products, including setting up inspection procedures, product specifications and qualify testing equipment. 建立和產(chǎn)品相關(guān)的測試能力，包括建立測試程序，產(chǎn)品標(biāo)準(zhǔn)并驗(yàn)證測試設(shè)備
-Set up and follow up the quality control plan 建立并跟蹤質(zhì)量控制計(jì)劃
- Take part in process validation. 參與過程確認(rèn)
Build up testing capacity regarding products, including setting up inspection procedures, product specifications and qualify testing equipment. 建立和產(chǎn)品相關(guān)的測試能力，包括建立測試程序，產(chǎn)品標(biāo)準(zhǔn)并驗(yàn)證測試設(shè)備
Operate inspection procedures 執(zhí)行測試程序
Train and qualify LQC 培訓(xùn)及考核LQC
Set up and follow up the quality control plan建立并跟蹤質(zhì)量控制計(jì)劃
Routine production:日常生產(chǎn)
-Perform WIP product release, and complete quality report 實(shí)施WIP產(chǎn)品放行，完成質(zhì)量報(bào)告
-Identify NCs and CAPAs in a systematic way, e.g. using statistical tools 系統(tǒng)地識別不合格和CAPA，例如，運(yùn)用統(tǒng)計(jì)工具
-Take responsibility for quality improvement 負(fù)責(zé)質(zhì)量改進(jìn)
-Cooperate with other Engineers for complaint investigation and close 與其它工程師協(xié)作完成投訴處理
- Perform batch record review to develop quality metric and drive defect reduction effort. 實(shí)施批記錄審閱，建立質(zhì)量指標(biāo)并驅(qū)動降低不良
Perform statistical analysis of process data interpret, compile and organize results. 實(shí)施過程數(shù)據(jù)的統(tǒng)計(jì)分析，解析并編輯組織
Address product quality issues and organize quality improvement 識別質(zhì)量問題，組織質(zhì)量改進(jìn)
Cooperate with other Engineers for failure investigation, including NCR, deviation and complaint, etc與其它工程師協(xié)作完成實(shí)效調(diào)查，包括不合格、偏差和投訴
Authorize to release in-process product & FG(If they meet the pre-defined spec) relating to his/her responsible product line. 授權(quán)放行與其責(zé)任產(chǎn)品相關(guān)半成品和成品
Other tasks defined in QMS. QMS 定義的其他職責(zé)
Comply with Company’s EHS policies, regulations and procedures

Job Specifications職位要求
- A bachelors degree in scientific or engineering discipline.
本科學(xué)歷，科學(xué)或工程背景
- Mechanical or Electrical education as a plus
機(jī)械或電子教育背景優(yōu)先考慮
-Minimum 4 years experience in quality field in manufacturing environment. 至少4年生產(chǎn)質(zhì)量經(jīng)驗(yàn)
-Experience in medical device and/or knowledge of a wide range of manufacturing technologies is desired. 醫(yī)療器械知識，通曉生產(chǎn)技術(shù)
- Experience in sterile device manufacturing as a plus
無菌器械生產(chǎn)優(yōu)先考慮
- Understand requirements of process/equipment validation
了解過程/設(shè)備確認(rèn)
- 6 sigma certificate as a plus
具有6 sigma 證書優(yōu)先考慮
- Fluent verbal and written English 流利的讀寫英語
- Good computer skill of Microsoft application software
計(jì)算機(jī)操作（微軟應(yīng)用程序）
- Good communication skill and team spirit
良好的溝通能力和團(tuán)體合作精神

Medtronic和Covidien攜手合作，通過更多方式以及在全球更多地方改善醫(yī)療保健，以滿足更多人的需求。作為一家公司，我們促進(jìn)并增強(qiáng)實(shí)現(xiàn)有意義創(chuàng)新的能力。但是，要取得成功，我們的團(tuán)隊(duì)必須擁有優(yōu)秀的人才。現(xiàn)在是加入我們并為改善更多人的健康作出貢獻(xiàn)的理想時(shí)機(jī)。

通過整合Medtronic和Covidien的資源，我們具備改革能力，并創(chuàng)造全新方法和新機(jī)遇。不論您的專長領(lǐng)域或理想抱負(fù)為何，Medtronic都會讓您大放光彩，讓您在幫助更多人改善生活的同時(shí)拓展自己的職業(yè)生涯。

Medtronic是一家市值278億美元的公司，它在全球超過160個國家擁有85000+名員工。

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.