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Position: QA Engineer 质保工程师+ B+ K8 [& q; B: U
Responsibilities/ Duties
2 p3 f" ~3 l9 V5 V# x1 J· 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 / ~! ^" [# ^+ s; [
· 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
* [; D/ Q+ U) v0 v& a· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训
9 y3 ^0 T+ e/ }! {- ^9 {& o· Participate in internal and external audits. 参与内部和外部审计 ' }% E4 D8 Y3 `6 W- l h/ P
· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度 5 D1 y+ N& J+ d/ ^. C& l! p7 L
· 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 ' ], A7 f% ~4 h5 J$ \* Q. n% Q) W) X
· 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
% @% q, n+ C: o$ t# vRequirements
) L# K9 `" \3 Z6 ^: J( d9 nKnowledge/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 5 j2 M9 T" Q' v" [8 m) r) e7 g
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/ l6 L: m( a, K4 v* k' c
Critical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China. # {2 C# e W0 \ \
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) q$ A$ M+ d- o1 _0 J R有意向给YAYA发 个消息。呵呵 |
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