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Position: QA Engineer 质保工程师
% f; R' {; L* v* M* Y8 R# X" GResponsibilities/ Duties ( g* Q" A) J' e6 ?. s1 f
· 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 3 E% Y, H! w1 P% s
· 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 % q3 w2 h' S. O& d
· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训 ; o/ k- X: m1 ?
· Participate in internal and external audits. 参与内部和外部审计
% c) }, I+ r* s0 d# }, C) o· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度
6 B& L! c ~2 B' d( P4 z( n· 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
$ M$ X) R4 K/ y8 {' b7 O· 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
7 z# J w1 ?4 }9 V# @Requirements ' r( c+ B3 b* s1 X% T
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 # E% m0 x4 U6 f2 n
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
# b: z: I/ o1 S* Z! f7 U: r: \( gCritical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China.
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