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Position: QA Engineer 质保工程师# o- p% h) L4 c2 Y+ H/ k
Responsibilities/ Duties % z) g A+ T% @7 Q! h) V; [" }
· 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
7 r y3 H( X, }) d0 Q( \; k* Y- d" @9 h· 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 E" J, c9 C0 c1 C/ C, ~, W
· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训 7 v2 f6 Z6 h, \8 ~0 \0 N
· Participate in internal and external audits. 参与内部和外部审计 4 c( M3 S' l; m9 l
· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度
1 E$ W9 m; k0 f) q" J" y· 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 i; B* s4 P* `, w' J8 l· 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 5 S0 D5 v. @ m- m; Q; z- z/ S
Requirements
% O. Q( g5 b$ f) g1 q5 |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 0 |9 K/ o1 H( {$ U% D( Z( j
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 : b0 Y: \$ {7 [; A) S" X
Critical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China.
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