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Position: QA Engineer 质保工程师2 u6 A) Z. U% C/ p4 h) I* g- S1 M
Responsibilities/ Duties
" K- k+ X" T, D+ O* W+ b· 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 - s9 j. W+ C3 B& { y( N1 {2 S/ i
· 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
4 B# h2 s& E: U$ S/ q/ ^+ H6 e· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训 & g. M4 M5 m/ F7 ]
· Participate in internal and external audits. 参与内部和外部审计 : B. x; k$ U* D8 p
· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度
V/ |. G' t9 Y0 B7 L2 f' M, v· 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 ]' \' |' D0 ?· 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% {. t" |, x3 m9 q8 G* t/ RRequirements
7 j( |, z* X# n7 C$ j ZKnowledge/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 / W& C7 R4 [* O1 Y
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 9 \& G; j! |8 @9 I
Critical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China.
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$ `2 T9 p4 q, Q" ~$ I3 v4 \8k, 川沙(上海). K( m* y4 e; ~2 f/ H) j
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