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Position: QA Engineer 质保工程师7 [# U- Q. r; f) P: u1 n3 j
Responsibilities/ Duties ) V& o6 A8 \6 D& D( m6 o) p
· 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 8 o$ i! s3 ` t% A% x: p) a# `
· 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
% K% l' u# f8 H2 O( y· Maintain the raining system and coordinate the new employees training 保养射线系统及新员工培训
# t3 `# y+ Z; f. S$ Y9 n· Participate in internal and external audits. 参与内部和外部审计 / q" b: A4 O' x4 H. x) [
· Monitor the performance of quality to increase customer satisfaction. 监测质量性能以提高客户满意度
& j( N! k" K( I· 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 ; ^. W4 }; T B* c% 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 " `- z. ~$ Z2 x7 ^5 D
Requirements
* \3 a' o" o0 q6 h0 z6 g! wKnowledge/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
- F+ U8 E, T; j+ vProfile 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
; H* n! w8 x- E! J# Z- ZCritical contacts Internal: All departments within the facility External: Suppliers, Customers, Notified Bodies, Government in China.
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8k, 川沙(上海）
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