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Job Description崗位職責(zé):
1. 主導(dǎo)全流程質(zhì)量管理體系的搭建、優(yōu)化，包括應(yīng)對(duì)政府機(jī)構(gòu)或藥監(jiān)部門飛行檢查。
Lead the establishment and optimization of end-to-end QMS, including handling unannounced regulatory inspections of any organization or government department.
2. 制定產(chǎn)品質(zhì)量檢驗(yàn)標(biāo)準(zhǔn)及新產(chǎn)品開發(fā)質(zhì)量策劃，主導(dǎo)試產(chǎn)風(fēng)險(xiǎn)評(píng)估與控制方案。
Define product quality inspection standards and new product development quality plans, leading trial production risk assessment and control strategies.
3. 分配質(zhì)檢團(tuán)隊(duì)的日常工作任務(wù)，提供檢測(cè)等的技術(shù)指導(dǎo)，根據(jù)實(shí)際情況安排質(zhì)檢員培訓(xùn)。
Assign the daily work tasks of the QC team, provide technical guidance on testing, etc., and arrange training for QC inspectors according to the actual situation.
4. 對(duì)采購(gòu)的原材料、包裝材料進(jìn)行入廠檢驗(yàn)，出具檢驗(yàn)報(bào)告，確保符合質(zhì)量標(biāo)準(zhǔn)。
Carry out incoming inspection of purchased raw materials and packaging materials and issue inspection reports to ensure compliance with quality standards.
5. 在生產(chǎn)過程中進(jìn)行關(guān)鍵工序檢驗(yàn)、監(jiān)督生產(chǎn)是否符合工藝規(guī)程。
Conduct key the Process Inspection during the production process and supervise whether the production is in accordance with the process regulations.
6. 對(duì)最終產(chǎn)品進(jìn)行成品檢驗(yàn)，確保產(chǎn)品符合注冊(cè)標(biāo)準(zhǔn)和出廠放行標(biāo)準(zhǔn)。
Execute the Finished Product Inspection on the final product to ensure that the product complies with the registration standard and factory release standard.
7. 如實(shí)填寫檢驗(yàn)記錄，發(fā)現(xiàn)不合格品和違規(guī)操作時(shí)及時(shí)上報(bào)質(zhì)量管理負(fù)責(zé)人，并參與不合格品評(píng)審。
Fill in inspection records truthfully, report to the person in charge of quality management when nonconforming products and irregularities are found and participate in the evaluation of nonconforming products.
8. 協(xié)調(diào)研發(fā)、生產(chǎn)及采購(gòu)部門推動(dòng)質(zhì)量前移，協(xié)助管代以及質(zhì)量負(fù)責(zé)人主導(dǎo)供應(yīng)商準(zhǔn)入評(píng)審及重大質(zhì)量事故（如客戶投訴）的閉環(huán)解決。
Coordinate R&D, Production, and Purchasing Department to drive quality upstream. Assist Management Representative and Quality Manager to lead supplier qualification reviews, and resolve critical quality incidents (e.g., customer complaints).
9. 建立供應(yīng)商評(píng)估機(jī)制，管理供應(yīng)商審核及能力提升項(xiàng)目，推動(dòng)來料質(zhì)量問題改進(jìn)閉環(huán)。
Develop supplier evaluation mechanisms, manage audit programs, and drive closed-loop improvements for incoming material quality issues.
10. 處理客戶投訴并主導(dǎo)根本原因分析，制定預(yù)防措施并匯報(bào)客戶滿意度改善進(jìn)展。
Handle customer complaints, conduct root cause analysis, implement preventive actions, and report on customer satisfaction improvement.
11. 推動(dòng)精益質(zhì)量項(xiàng)目以降低質(zhì)量成本（COQ），優(yōu)化不合格品處理流程。
Drive lean quality projects to reduce cost of quality (COQ), optimize non-conforming product handling.
Job Requirement崗位要求：
1. 本科及以上學(xué)歷，機(jī)械/電工/生物醫(yī)學(xué)工程或相關(guān)專業(yè)背景。
Hold a bachelor’s degree or higher in Mechanical/Electrician/Biomedical Engineering or related fields.
2. 具備3年以上醫(yī)療器械行業(yè)的質(zhì)量監(jiān)管經(jīng)驗(yàn)及2年團(tuán)隊(duì)管理或跨部門項(xiàng)目主導(dǎo)經(jīng)驗(yàn)。
Possesses 3+ years of quality inspection in medical devices industries and 2 years leading teams or cross-functional projects.
3. 精通ISO 13485/GMP標(biāo)準(zhǔn)并持有醫(yī)療器械內(nèi)審員資質(zhì)。
Demonstrate proficiency in ISO 13485/GMP standards and hold medical device internal auditor certification.
4. 能夠獨(dú)立開展檢驗(yàn)工作、指導(dǎo)質(zhì)檢團(tuán)隊(duì)并協(xié)調(diào)生產(chǎn)、研發(fā)、供應(yīng)鏈資源實(shí)現(xiàn)質(zhì)量目標(biāo)。
Be capable of conducting inspection work independently and mentor QC teams and coordinate production/R&D/supply chain resources to achieve quality objectives.
5. 擁有質(zhì)量成本優(yōu)化意識(shí)，及供應(yīng)商的質(zhì)量管理經(jīng)驗(yàn)。
Have an awareness of quality cost optimization and experience in supplier quality management.
6. 具有木材、鋼材、電氣件的檢驗(yàn)經(jīng)驗(yàn)優(yōu)先。若有與電工相關(guān)專業(yè)知識(shí)也可優(yōu)先考慮。
Experience in the inspection of wood, steel, and electrical parts is preferred. Specialized knowledge related to electrical work is also preferred.
7. 具備出色跨部門溝通能力和一定的抗壓能力。
Exhibit exceptional cross-functional communication skills and stress resilience.
8. 擁有外企工作經(jīng)驗(yàn)優(yōu)先。
Foreign company working experience preferred.
9. 擁有基礎(chǔ)的英語讀寫能力。
Having basic English reading and writing skills.