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Position: QA Engineer 质保工程师2 w6 F3 e- P \& Q: U7 [2 M$ f( Z9 `
Responsibilities/ Duties
, l' E) i( c( P$ S: l+ u· 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 I4 O& X, G6 s! f m
· 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
0 Y+ O& x0 p5 e, t2 R6 }· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训 5 ^8 B: i" O' s) u! {
· Participate in internal and external audits. 参与内部和外部审计
" H! L1 T5 j; e· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度 6 {( w# y. ]: p7 C0 j" W- [% R
· 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 ; {2 h3 e9 q. C8 \
· 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 , K* p7 \+ m9 _- [
Requirements 6 }- m; h6 i1 w7 X" l1 Q
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 ) D6 M) G- r7 U: \
Profile 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 " U" m& F. Y( r- y2 Q* r4 H! x
Critical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China.
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# ^7 `' d1 h' G, n8k, 川沙(上海)- E9 f3 a+ ^8 A5 u* s5 l, [3 l- Q4 Z
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