南京 [切换城市] 南京招聘南京质量管理/安全防护招聘南京质量检验员/测试员招聘

QA Specialist

波科国际医疗贸易(上海)有限公司

  • 公司性质:外资(非欧美)
  • 公司行业:贸易/进出口

职位信息

  • 发布日期:2017-11-30
  • 工作地点:上海-黄浦区
  • 工作经验:无工作经验
  • 职位月薪:8-10万/年
  • 职位类别:质量检验员/测试员  

职位描述

职位描述:
Complaints & Adverse Event handling management:
? Ensure over 95% complaints reported to relevant sourcing company in 4 working days;
? Ensure average complaints samples back to sourcing company within 15 days;
? Ensure 99.7 % reportable MDV (Local & Oversea) will be reported to CFDA within requirements;
Field action & QN management:
? Ensure 100% Field action will be received and analyzed it with the relevant people;
? Ensure 100% communication package localization when necessary;
? Ensure 100% Field Action will be communicated with customer according to BSC KPI. And communicated it with CFDA when necessary;
? Contact and inform regional Post-Market Surveillance Officer on Field action & QN completion;
? Tracking and Inform OPS on QN disposition timely;
Post Market Surveillance monitoring:
? Support with the traceability and recording of all compulsory related data monthly;
Quality system management:
? Support to develop and maintain BSC China procedures related to Post Market Surveillance together with QA Manager;
? Support to develop BSC China training related to Post Market Surveillance together with QA Manager;
Other tasks assigned by Department & company:
? Renew company license;
? Support RA to provide the complaint and MDV data for renew registration certificate. etc.

职能类别: 质量检验员/测试员

公司介绍

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