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1. Be the primary responsible person for product quality shipped out from the manufacturing site.

作為從制造現(xiàn)場(chǎng)發(fā)運(yùn)的產(chǎn)品質(zhì)量的主要負(fù)責(zé)人。

1. Ensure manufacturing processes and products consistently meet internal quality standards and regulatory requirements.

確保制造流程和產(chǎn)品始終符合內(nèi)部質(zhì)量標(biāo)準(zhǔn)和法規(guī)要求。

1. Lead all aspects related to product acceptance and release activities.

領(lǐng)導(dǎo)所有與產(chǎn)品驗(yàn)收和發(fā)布活動(dòng)相關(guān)的各個(gè)方面。

1. Implement and maintain robust quality control measures to uphold a high standard of product quality.

實(shí)施并維護(hù)穩(wěn)健的質(zhì)量控制措施，以保持高標(biāo)準(zhǔn)的產(chǎn)品質(zhì)量。

1. Guide and lead the team during the product development phase, emphasizing process validations.

在產(chǎn)品開(kāi)發(fā)階段指導(dǎo)和領(lǐng)導(dǎo)團(tuán)隊(duì)，強(qiáng)調(diào)過(guò)程確認(rèn)。

1. Implement and maintain the nonconformance report program; Investigate and address nonconformances promptly to promote a culture of continuous improvement.

實(shí)施并維護(hù)不合格報(bào)告程序；及時(shí)調(diào)查并解決不合格問(wèn)題，以促進(jìn)持續(xù)改進(jìn)的文化。

1. Manage changes in manufacturing process with a focus on quality, ensuring proper validation and documentation.

管理制造過(guò)程的變更，重點(diǎn)關(guān)注質(zhì)量，確保適當(dāng)?shù)尿?yàn)證和文檔記錄。

1. Ensure quality oversight of manufacturing processes, production test methods/specifications, and finished product release activities.

確保對(duì)制造流程、生產(chǎn)測(cè)試方法/規(guī)范和成品放行活動(dòng)進(jìn)行質(zhì)量監(jiān)督。

1. Establish and manage the product bioburden program, emphasizing the importance of quality at every stage.

建立并管理產(chǎn)品生物負(fù)載程序，強(qiáng)調(diào)每個(gè)階段的質(zhì)量重要性。

1. Partner with manufacturing to ensure appropriate facilities for the production of medical devices are established and maintained.

通過(guò)與制造部門合作，確保建立并維護(hù)適當(dāng)?shù)尼t(yī)療設(shè)備生產(chǎn)設(shè)施。

1. Collaborate effectively with internal customers to ensure seamless alignment with quality standards.

與內(nèi)部客戶有效協(xié)作，確保與質(zhì)量標(biāo)準(zhǔn)的無(wú)縫對(duì)接。

1. Provide visionary leadership to a team of engineers and quality professionals.

對(duì)工程師和質(zhì)量專業(yè)人員團(tuán)隊(duì)提供有遠(yuǎn)見(jiàn)的領(lǐng)導(dǎo)力。

1. Actively champion a quality culture throughout the organization; and foster a culture of continuous improvement and adherence to quality standards; and to instill a commitment to quality throughout the organization.

在整個(gè)組織內(nèi)積極倡導(dǎo)質(zhì)量文化；培養(yǎng)持續(xù)改進(jìn)和遵守質(zhì)量標(biāo)準(zhǔn)的文化；并在整個(gè)組織中灌輸對(duì)質(zhì)量的承諾。

1. Actively coach and mentor staff on the principles of quality excellence.

積極指導(dǎo)和輔導(dǎo)員工以推行質(zhì)量卓越原則。

1. Establish strong working relationships across functions to ensure product quality at every stage of the manufacturing process.

建立牢固的跨部門工作關(guān)系，以確保制造過(guò)程的每個(gè)階段的產(chǎn)品質(zhì)量。

1. Participate enthusiastically in QE/QMS activities, contributing to overall quality culture.

積極參與質(zhì)量工程/質(zhì)量管理體系活動(dòng)，為整體質(zhì)量文化做出貢獻(xiàn)。 任職要求：

1. 統(tǒng)招本科或以上學(xué)歷（機(jī)械工程、電氣電子工程、系統(tǒng)工程、生命科學(xué)或相似領(lǐng)域），具有質(zhì)量管理、認(rèn)證管理、設(shè)備管理、生產(chǎn)管理等相關(guān)專業(yè)知識(shí)。
2. 5年或以上醫(yī)療器械相關(guān)行業(yè)工作經(jīng)驗(yàn)，3年或以上質(zhì)量管理工作經(jīng)驗(yàn)，3年或以上團(tuán)隊(duì)管理工作經(jīng)驗(yàn)。
3. 熟悉醫(yī)療器械質(zhì)量管理體系的法規(guī)、標(biāo)準(zhǔn)、政策，質(zhì)量意識(shí)強(qiáng)，了解行業(yè)發(fā)展情況，懂得企業(yè)質(zhì)量管理實(shí)務(wù)。
4. 具有檢驗(yàn)規(guī)程、測(cè)試方法開(kāi)發(fā)與確認(rèn)的管理經(jīng)驗(yàn)。
5. 具備統(tǒng)計(jì)學(xué)理論與工具的知識(shí)與實(shí)踐，能定義樣品容量和進(jìn)行數(shù)據(jù)分析。
6. 具有風(fēng)險(xiǎn)分析、FMEA、危害分析、幾何尺寸與公差（GD&T）經(jīng)驗(yàn)。
7. 具有ISO 13485內(nèi)審員、6 Sigma綠帶等資質(zhì)者優(yōu)先。
8. 熟練使用Microsoft Office等辦公軟件。
9. 英語(yǔ)CET-4或同等水平，聽(tīng)說(shuō)讀寫熟練。
10. 具有獨(dú)立思考能力，主觀能動(dòng)性強(qiáng)，工作認(rèn)真細(xì)致，邏輯性強(qiáng)，原則性強(qiáng)，有較強(qiáng)的溝通協(xié)調(diào)、語(yǔ)言表達(dá)和文字處理能力，良好的團(tuán)隊(duì)合作精神。