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Position: QA Engineer 质保工程师
?5 P4 n0 J7 ^6 U9 W* g2 {3 G# U' zResponsibilities/ Duties
/ b; s) X: y! x1 a/ t· 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 & X/ j, S" T' e( F
· 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
1 I+ [ } c, |% }1 c0 q- K2 x· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训
2 m; q+ k, K# t1 L3 ]· Participate in internal and external audits. 参与内部和外部审计 : \. k4 K* m! q% f0 ~
· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度 * l# l9 K8 J7 e5 _; j; K1 G+ S
· 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 9 n0 g0 W3 {, z( F
· 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
" g& ]9 d$ F# w) @% s6 h/ mRequirements
# ?( ]4 O1 d5 a" Z; JKnowledge/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 % [% K! o9 C* F& D: ^: w
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
, G; F% h' X& I- j$ R8 l1 R) k& @8 wCritical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China.
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