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Position: QA Engineer 质保工程师
4 [6 Q' I @; @9 L* V, i" T/ YResponsibilities/ Duties
) U7 F* t0 P0 T0 V7 }· 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
: B1 [ I, S2 o b- r+ g· 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' r# E/ e: d; s4 D· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训 / ]; C6 O6 x( G) F; T7 Q
· Participate in internal and external audits. 参与内部和外部审计
[5 w: [* h, \( s) f· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度
: U( m& j1 [& I+ K· 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 8 v. x$ T1 a$ F) l2 |8 D* b0 r! W
· 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 - I3 `/ D d3 b
Requirements & _5 `# h1 D) s
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
C$ q7 {& Y( c! I# G4 GProfile 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
$ ^! r4 y9 t* a3 ~0 [' ~Critical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China. 8 Y; k1 I5 ?6 O5 M/ e, @& G
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- L# B6 W* t) P# l$ A8k, 川沙(上海)" ?6 D' `5 y5 X; u( W5 i2 F
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