Job Deion:
Product/process validation:產品/過程確認
1 Lead new product/process validation, including DQ, IQ, OQ and PQ stages.
主導新產品及新工藝確認,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品/新工藝控制計劃,潛在實效模式,測量協議和測試計劃
4 Yearly baseline checking for validated product/process.
每年對已確認的產品及工藝進行基線參數檢查
Customer complaint :客戶投訴
1 As a contact window of customer complaint and forward related information to internal team.
客戶投訴的聯系窗口,并及時把相關信息傳達給內部
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行
3 Finish customer complaint report.
完成客戶投訴報告
Continuous improvement activities:持續改善活動
1 Review internal deviation reports issued by production team or technical team, and give comments.
評審生產部/技術部發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,把內部偏差報告發給客戶并關閉
3 Follow up corrective and preventive s for internal deviation.
跟蹤內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/技術部新的或更新的作業指導書
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.
批準生產工單
2 Defective parts judgment and sign the limit sample for internal team.
內部不良品判斷及簽署限度樣件
3 Uniform inspection method between production and QC team.
統一生產及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.
做內部偏差的產品合作人及協調員
6 Other work assigned by quality assurance supervisor or quality manager.
其它主管或經理指派的工作
Qualification：
1 Good English skills in both writing and oral.
英語讀寫技能良好
2 Skills in “Good documentation practice”.
有良好文件操作規范的經驗
3 Internal audit experience.
有內審經驗
4 Have worked with ISO13485, minimum ISO9001 or TS16949.
有ISO13485經驗，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,測量系統分析
7 Have worked with "change control", "CAPA" or "validation".
有變更控制，CAPA或確認經驗

醫樂世（天津）醫療器械技術有限公司，成立于2010年1月，坐落于西青開發區賽達國際工業城，是瑞典ELOS AB公司在中國投資的全資子公司，公司主要生產醫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。公司提供市區班車、午餐、年度健康體檢，為員工上六險一金，按照當地法規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境，讓我們一起開創美好的未來。

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路到賽達國際工業城內“靈北制藥站”下車，或從大寺鎮打車前往。