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Position: QA Engineer 质保工程师
6 N8 t' F2 B; ]3 q) P& X% K2 lResponsibilities/ Duties
& E5 K* ~+ X- O" [" ?1 L1 o0 M· Document control 文件管理 · Assist the QA manager to maintain compliance to the requirements established in the quality management system 协助质量经理保持符合规定要求的质量管理体系
9 F9 y7 @; d5 Q: U3 H1 o4 M2 q) \· Supplier manager · Establish, maintain and improve facility work instruction, develop quality monitor for irradiation process. 建立,维护和改善工作设备指示,制定辐射进程质量监测 * m+ x+ f9 G' v9 t- f% ?. ?
· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训
9 ]% p: o$ T" D8 ~0 Q# _" l) l7 d6 [· Participate in internal and external audits. 参与内部和外部审计 3 w/ {+ F, ^1 L6 g% }1 c
· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度 8 }+ D! ]$ L! l7 k5 p* A% |
· Report to the QA Manager on the performance of the quality issues and any need for improvement. 向质量经理汇报质量进程及任何改进需要
+ b9 ~; X: M# A* B- N· Manage QA activities, other tasks assigned by QA Manager. 管理质保行为,执行质保经理安排的任务
- G5 ~: f& B& a G! T" |1 { Q+ mRequirements
1 n$ i7 {/ Q4 L. a3 P5 T0 T6 [+ t6 ?Knowledge/education and training: University degree 本科以上学历 Quality Systems & standards ISO 13485: 2003, ISO 9001:2000熟悉ISO 13485: 2003, ISO 9001:2000等质量体系与标准 i Experience/skills: Relevant experience in QA system work (Min. 3 years)质保相关工作经验3年以上 Experience in the pharmaceutical or medical device industry is an advantage. 医疗设备或制药生产企业工作经历 Experience in auditing 质量体系审计经验 Fluent in English (reading, speaking, writing). 英语听说读写流利
+ J) A& o+ }9 J6 m' fProfile Good communication skills on all levels. 良好的沟通技巧 Open minded, and self-motivated. 开朗、自我激励型 Efficient, accurate, work according to plan. 高效精准的执行力 Flexible. 灵活变通 Problem solving attitude. 解决问题的态度 High commitment to quality 质量的高承诺
5 e- k# l: p4 K" q6 WCritical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China. ( d: u9 Q- R/ J0 K, B2 u
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, V* U4 T* Z2 Z9 ?4 [" H8k, 川沙(上海)% G# J( R( R# {; E( M2 ~9 y9 ^4 Y& D* ^6 e
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