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Position: QA Engineer 质保工程师3 h4 q( U/ ], N% {% }& L0 x/ @+ b
Responsibilities/ Duties
/ a: G; b7 o& p9 N! P9 b" y· 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 ' g K5 q) O+ | b" A7 T
· 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 7 ^0 n1 h3 L) w$ {, P) L
· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训
; y- R/ k$ y) L4 F9 Q, m" `· Participate in internal and external audits. 参与内部和外部审计 {) a2 h! |4 F: h* Z( `
· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度 6 ~; J( Z' J0 ]. Y' 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 * X" t$ `; a0 l4 H% l/ H. k
· 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
- A$ X1 |9 g0 ^1 ?% a) o" zRequirements ! i5 e. s- _* |) s+ m$ Z+ g2 V
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
9 E J9 m P" M6 I; i- G1 b5 JProfile 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 - i5 p6 ?8 Z# M8 G0 {
Critical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China. , {9 C; R2 z6 j% P
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8k, 川沙(上海)
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