Key Responsibilities

1. 根據(jù)MVP 執(zhí)行過程確認及軟件確認工作
   Be responsible for the process validation and software validation according MVP;
2. 負責根據(jù)材料及產(chǎn)品功能，制定檢驗計劃， 包含進料檢驗， 過程檢驗控制及最終產(chǎn)品的檢驗。建立所有的產(chǎn)  品檢驗標準及產(chǎn)品放行確認。
   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.  負責已經(jīng)IOVV及其他產(chǎn)品規(guī)范進行產(chǎn)品風險分析文檔的修訂及更新。
    Be responsible for product risk file modification and upgrade per IOVV and other product specification.
4.  負責不符合報告和客戶投訴的調(diào)查，分析及追蹤， 并在MC 系統(tǒng)完成相關(guān)報告。
    Be responsible for nonconformity and complaints investigation, analysis and follow up, finish NC report and    complaints report in MC.
5.  負責新產(chǎn)品設(shè)計轉(zhuǎn)移。
    Be responsible for new product design transfer.
6.  協(xié)助CAPA 過程。
    Support CAPA process from quality respective.
7.  供應(yīng)商評估， 管理， 績效考核及PPAP 過程。
    Be responsible for supplier evaluation , management , performance review and PPAP process.
8.  檢驗人員培訓， 管理。
    Inspector training and management.

9.  Class8 無塵室的管理。

    Manage the Class8 clean room.

Qualifications:

         1. 3-5年質(zhì)量過程控制經(jīng)驗。

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

2.有ISO13485 質(zhì)量體系管理經(jīng)驗優(yōu)先。

  Have ISO13485 system management is plus

3.有供應(yīng)商管理經(jīng)驗。

Supplier management experience is plus.