Job Deion:
Product/process validation:產(chǎn)品/過程確認
1 Lead new product/process validation, including DQ, IQ, OQ and PQ stages.
主導新產(chǎn)品及新工藝確認,包括DQ, IQ, OQ 和 PQ各階段
2 Ridation for validated product or process every 5 years.
每5年對已確認的產(chǎn)品及工藝進行在確認.
3 Lead a cross-function team to finish control plan, FMEA, MA and test plan for new product/process.
領導跨職能小組完成新產(chǎn)品/新工藝控制計劃,潛在實效模式,測量協(xié)議和測試計劃
4 Yearly baseline checking for validated product/process.
每年對已確認的產(chǎn)品及工藝進行基線參數(shù)檢查
Customer complaint :客戶投訴
1 As a contact window of customer complaint and forward related information to internal team.
客戶投訴的聯(lián)系窗口,并及時把相關信息傳達給內(nèi)部
2 Handling customer complaints, including root cause analyses and implementation of corrective s and preventive s
處理客戶投訴,包括根本原因分析和糾正預防措施的執(zhí)行
3 Finish customer complaint report.
完成客戶投訴報告
Continuous improvement activities:持續(xù)改善活動
1 Review internal deviation reports issued by production team or technical team, and give comments.
評審生產(chǎn)部/技術部發(fā)起的測試方案和測試報告,并給出建議
2 Send internal deviation report to customer if need and close it.
如果需要,把內(nèi)部偏差報告發(fā)給客戶并關閉
3 Follow up corrective and preventive s for internal deviation.
跟蹤內(nèi)部偏差的糾正預防措施
4 Approve new WI or updated WI issued by production team or technical team.
批準生產(chǎn)/技術部新的或更新的作業(yè)指導書
5 Review test protocol and test report for process improvement.
評審過程改進的測試方案
6 Review and close CAPA project if need.
如果需要評審并關閉CAPA項目
Daily work:日常工作
1 Approve new route card from production.
批準生產(chǎn)工單
2 Defective parts judgment and sign the limit sample for internal team.
內(nèi)部不良品判斷及簽署限度樣件
3 Uniform inspection method between production and QC team.
統(tǒng)一生產(chǎn)及QC的檢驗標準
4 Participate internal audit, customer audit and 3rd party audit, and follow up corrective and preventive s if need.
參加內(nèi)審,客戶審核及第三方審核,跟蹤糾正預防措施(如果需要)
5 products partner and coordinator for internal deviation.
做內(nèi)部偏差的產(chǎn)品合作人及協(xié)調員
6 Other work assigned by quality assurance supervisor or quality manager.
其它主管或經(jīng)理指派的工作
Qualification：
1 Good English skills in both writing and oral.
英語讀寫技能良好
2 Skills in “Good documentation practice”.
有良好文件操作規(guī)范的經(jīng)驗
3 Internal audit experience.
有內(nèi)審經(jīng)驗
4 Have worked with ISO13485, minimum ISO9001 or TS16949.
有ISO13485經(jīng)驗，至少懂得ISO9001 或 TS16949
5 Have problem solving skills as “8D”, "5 Why","DMAIC" or similar.
有“8D”, "5 Why","DMAIC"相關技能
6 Knowledge about "control plan","FMEA","MSA" etc.
了解控制計劃,潛在實效模式,測量系統(tǒng)分析
7 Have worked with "change control", "CAPA" or "validation".
有變更控制，CAPA或確認經(jīng)驗

醫(yī)樂世（天津）醫(yī)療器械技術有限公司，成立于2010年1月，坐落于西青開發(fā)區(qū)賽達國際工業(yè)城，是瑞典ELOS AB公司在中國投資的全資子公司，公司主要生產(chǎn)醫(yī)療器械和精密機械零部件等，擁有高精密加工工藝和嚴格的質量控制體系。在瑞典、丹麥、美國均設有子公司。目前員工人數(shù)120人。

作為一家來自瑞典的公司，北歐的管理風格，開放的辦公環(huán)境，和諧的人文氛圍，公司不斷提高客戶滿意的同時，也在不斷完善員工各項福利。公司提供市區(qū)班車、午餐、年度健康體檢，為員工上六險一金，按照當?shù)胤ㄒ?guī)要求支付防暑降溫費、取暖費、中夜班津貼等。全員全年享有12天以上年假并逐年增加（上限20天），節(jié)日紅包、生日紅包、健康年度體檢等福利。
希望有識之士加盟，公司會為其提供良好的培訓機會及工作環(huán)境，讓我們一起開創(chuàng)美好的未來。

請詳見公司地理位置圖或使用百度地圖、谷歌地圖搜索“醫(yī)樂世”了解公司具體位置。
面試者可公交換乘708路到賽達國際工業(yè)城內(nèi)“靈北制藥站”下車，或從大寺鎮(zhèn)打車前往。