质量控制工程师

Key Responsibilities

1. 根据MVP 执行过程确认及软件确认工作
   Be responsible for the process validation and software validation according MVP;
2. 负责根据材料及产品功能，制定检验计划， 包含进料检验， 过程检验控制及最终产品的检验。建立所有的产  品检验标准及产品放行确认。
   Be responsible for  the incoming inspection process, in process quality control process, final product release process control, set up all the inspection standard, in process control standard and product final release standard;
3.  负责已经IOVV及其他产品规范进行产品风险分析文档的修订及更新。
    Be responsible for product risk file modification and upgrade per IOVV and other product specification.
4.  负责不符合报告和客户投诉的调查，分析及追踪， 并在MC 系统完成相关报告。
    Be responsible for nonconformity and complaints investigation, analysis and follow up, finish NC report and    complaints report in MC.
5.  负责新产品设计转移。
    Be responsible for new product design transfer.
6.  协助CAPA 过程。
    Support CAPA process from quality respective.
7.  供应商评估， 管理， 绩效考核及PPAP 过程。
    Be responsible for supplier evaluation , management , performance review and PPAP process.
8.  检验人员培训， 管理。
    Inspector training and management.

9.  Class8 无尘室的管理。

    Manage the Class8 clean room.

Qualifications:

         1. 3-5年质量过程控制经验。

  Have one to two years working experience in medical device field。

2.有ISO13485 质量体系管理经验优先。

  Have ISO13485 system management is plus

3.有供应商管理经验。

Supplier management experience is plus.