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Position Summary / 職位概況
Requirements / 要求
Education / 教育背景
Bachelor or above, major in mechanical or engineering is preferred.
本科及以上學(xué)歷，機(jī)械或工程類(lèi)專(zhuān)業(yè)
Experience /經(jīng)驗(yàn)
More than 5 years in Quality Assurance or related functional area.
五年以上質(zhì)量控制和相關(guān)領(lǐng)域工作經(jīng)驗(yàn)
Other skills /其他技能
1. Must be able to analyse and resolve non-routine product issues using independent judgment and inspection equipment.
具備獨(dú)立地判斷能力，能夠使用檢測(cè)設(shè)備分析并解決非常規(guī)類(lèi)產(chǎn)品的相關(guān)問(wèn)題
2. Strong analytical skills, familiar with QC tools. Familiar with statistical tools is preferred.
較強(qiáng)的分析能力，熟練使用質(zhì)量工具。熟悉統(tǒng)計(jì)工具尤佳。
3. Familiar with ISO 13485, & ISO 9001. Internal auditor is preferred. Familiar with FDA QSR820, & CFDA regulation is preferred.
熟悉質(zhì)量管理體系ISO 13485和ISO 9001. 內(nèi)審員，熟悉FDA QSR820和CFDA法規(guī)尤佳。
4. Basic inspection techniques. Familiar with optical instruments is preferred.
基本的檢驗(yàn)技能，熟悉光學(xué)檢驗(yàn)設(shè)備尤佳。
5. Lean knowledge is preferred.
了解精益知識(shí)尤佳。
6. Familiar with office software, SAP QM operation is preferred.
熟練使用辦公軟件，熟悉SAP QM操作尤佳。
7. Oral and written English skills.
良好的口頭和書(shū)面英語(yǔ)能力
8. Responsible and positive, can work under pressure.
有責(zé)任心，樂(lè)觀的態(tài)度，能夠在壓力下工作。
9. Excellent communication and coordination skills.
良好的溝通和合作能力

Main Tasks / 主要任務(wù)
1. Quality planning of product, to ensure quality level compliance with design/customer requirement continuously.
產(chǎn)品質(zhì)量策劃，以保證其質(zhì)量水平持續(xù)符合設(shè)計(jì)/客戶的要求。
2. Create IQC inspection plan of critical components.
創(chuàng)建關(guān)鍵元器件的來(lái)料檢驗(yàn)計(jì)劃。
3. Create and maintain test instruction of semi-product and finished product. Train and certified inspectors and operators.
創(chuàng)建并維護(hù)半成品，成品檢驗(yàn)指導(dǎo)書(shū)，培訓(xùn)并認(rèn)證檢驗(yàn)員和作業(yè)員。
4. Create and maintain DMR. Support manufacturing engineer for related project documents of medical device, such as FMEA, verification and validation, etc., as well as line trouble shooting and improvement project.
創(chuàng)建并維護(hù)DMR，協(xié)助制造工程師完成醫(yī)療器械相關(guān)項(xiàng)目文件，比如FMEA，驗(yàn)證，確認(rèn)文檔等。協(xié)助制造工程師的在線不良分析以及改善項(xiàng)目。
5.根據(jù)檢驗(yàn)指導(dǎo)書(shū)檢驗(yàn)產(chǎn)品。
Inspect the product according to the test instructions.
6. Participant change control board and implement engineering change order accordingly.
參加工程變更會(huì)議，并執(zhí)行工程變更的要求。
7. Handle internal customer complaint, including necessary corrective and protective actions follow. Provide containment suggestion, regarding to end customer complaint.
處理內(nèi)部客戶投訴，跟蹤必要的糾正和預(yù)防措施。針對(duì)外部客戶投訴，提供圍堵措施的方案。
8. Provide technical solution, as per other departments’ requirement.
應(yīng)其他部門(mén)需求，提供技術(shù)方案。
9. Continuous improvement of quality and environment integration system
對(duì)質(zhì)量和環(huán)境整合體系進(jìn)行持續(xù)的推進(jìn)和改善工作。
10.Review product outgoing inspection result and report, release product.
審核產(chǎn)品出貨檢驗(yàn)記錄和報(bào)告，放行產(chǎn)品。
11. Review verification documents and the updated DHFs for sustaining products.
評(píng)審進(jìn)入維持階段的產(chǎn)品驗(yàn)證報(bào)告以及更新的DHF
12. Other duties, as assigned.
其他領(lǐng)導(dǎo)分配的任務(wù)。