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工作職責(zé)(Responsibilities):
1. 制定新項目導(dǎo)入的品質(zhì)保證和合規(guī)性要求，并審閱和修訂相關(guān)的質(zhì)量協(xié)議和合規(guī)性聲明及產(chǎn)品注冊要求；
Set the quality assurance and regulatory compliance request for new project transfer, review and revision the related quality agreement and compliance certification and registration request.
2. 參與新產(chǎn)品過程開發(fā)，識別各過程中的風(fēng)險并制定風(fēng)險控制措施；
Take part in new process development for new product, identify the risks from the new process and define proper activities to control the risks.
3. 參與制定過程驗證主計劃并審核OQ和PQ，確保過程風(fēng)險點被有效驗證；
Participate to create VMP (validation Master Plan), and review OQ (Operation Qualification) and PQ (Performance Qualification) to ensure all risks be validated effectively.
4. 制定產(chǎn)品外觀標(biāo)準(zhǔn)并與客戶達成一致；
To align cosmetic criteria with customer.
5. 建立產(chǎn)品測試方法并實施TMV (Test Method Validation)；
Establish specific test method for product and implement TMV.
6. 建立適當(dāng)?shù)能囬g環(huán)境及微生物控制流程以滿足產(chǎn)品滅菌要求；
Establish control procedure for new product to meet sterilization requirement.
7. 建立過程控制計劃以及相關(guān)檢驗WI；
Create process control plan and related work instruction for inspection.
8. 建立物料可接受標(biāo)準(zhǔn)，并完成物料檢驗WI；
Align material acceptance criteria, and establish work instruction for incoming material.
9. 評估供應(yīng)商的測試方法和驗證結(jié)果；
Align test/inspection method with vendor, such as tooling selection, TMV protocol, etc.
10. 確認(rèn)打樣物料的符合性。
Verify if incoming materials meet the requirements, which are for prototype sample building.

任職資格(Qualification) :
1. 本科及以上學(xué)歷，6年以上醫(yī)療器械品質(zhì)保證工作經(jīng)歷；
Above Bachelor degree, and more than 6 years quality assurance work experience for medical device;
2. 熟悉新產(chǎn)品開發(fā)流程及基礎(chǔ)的品質(zhì)工具(SPC/ MSA/ PFMEA/ Control Plan/ APQP/ PPAP)；
Familiar with new product development procedure and basic quality tools.
3. 英語能作為工作語言；
English can be used for communicating as normal.