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Position: QA Engineer 质保工程师0 c* X3 C" \4 C$ P% e; y% p# p
Responsibilities/ Duties
3 U, m- L: I9 n3 \ Q7 E· 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 # R5 S* S) |0 v" N$ b) w$ h+ l) b! I" n
· 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
; @* A/ f4 ?4 B/ l6 n% O· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训 - O6 w2 \, f' x5 X4 e. {! j9 q2 F
· Participate in internal and external audits. 参与内部和外部审计 + q' |! i" E; Y% C7 i! }. w, h
· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度
7 B) D) k$ R. K, ? y3 a" m· 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 5 ]' ]% m- T9 L" X5 e& _9 s
· 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 : j8 I- v# ^! \2 y4 X, x
Requirements
1 X- Z% v1 o) e# Y6 q' QKnowledge/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
: v. d1 g; d5 M6 M/ \2 h2 L& `/ pProfile 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
8 _' D4 Z+ v9 J5 QCritical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China. : `. a5 [" H, D: V
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