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Position: QA Engineer 质保工程师
- M6 B% h6 ^( _" P2 MResponsibilities/ Duties 2 `$ ?3 J; C: I* \. 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
' E, c8 H: e5 E7 D7 q· 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 ) L, r, m: ~2 D
· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训 2 u: ~) ^, m5 D g
· Participate in internal and external audits. 参与内部和外部审计
1 `. c; r6 p8 t ^( @# S· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度 6 e, u9 s5 d4 [# n3 H m/ L
· 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$ {, F7 w% M N
· 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
- Z: z/ ]* R6 h8 _. _. vRequirements 7 X) e2 X, s' w
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
8 f5 }5 P) X# a9 WProfile 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
* U& L' v' r$ n/ R$ KCritical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China.
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