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è·ä½è·è²¬(zé) (ç°¡(jiÇŽn)è¦èªªæ˜Ž)
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? Responsible for new product quality plan and make sure compliance of medical device regulation and quality system
? Responsible for legacy product maintenance and continuous improvement.
? Responsible for customer complain investigation, risk analysis, corrective and preventive action, effectiveness, handle customer complaint in time, continuous improve the customer satisfactions,
? Responsible for organize related department on non-conforming product review and disposition.
? Drive and implement process improvements to achieve First Time Quality (e.g. Error proofing, Measuring Automation activities, Yield improvements)
? è² (fù)責(zé)新產(chÇŽn)å“質(zhì)é‡ç®¡ç†ç–劃, 確ä¿å…¶é†«(yÄ«)療器械法è¦(guÄ«)和體系的符åˆæ€§;
? è² (fù)責(zé)è€ç”¢(chÇŽn)å“çš„ç¶è·(hù)å’ŒæŒçºŒ(xù)改進(jìn)ï¼›
? è² (fù)責(zé)客訴的調(dià o)查ã€é¢¨(fÄ“ng)險(xiÇŽn)分æžã€ç³¾æ£å’Œé (yù)防措施åŠå…¶æœ‰æ•ˆæ€§, åŠæ™‚(shÃ)處ç†å®¢è¨´ï¼ŒæŒçºŒ(xù)æå‡å®¢æˆ¶æ»¿æ„度；
? è² (fù)責(zé)組織相關(guÄn)部門å°(duì)ä¸åˆæ ¼å“è©•(pÃng)審和處置。
? é©…(qÅ«)å‹•(dòng)和實(shÃ)æ–½éŽç¨‹æ”¹é€²(jìn)，é”(dá)æˆFTQ（First Time Quality）（如防錯(cuò)ã€è‡ªå‹•(dòng)測(cè)é‡ã€æ高產(chÇŽn)é‡ï¼‰ã€‚
主è¦å·¥ä½œå…§(nèi)容/è·è²¬(zé)（列舉清單）
Responsibility （List）
? Responsible for new product quality planning, ensure compliance with medical regulation and system requirement.
? Responsible for legacy product maintenance and continuous improvement.
? Responsible for customer compliant investigation, risk analysis, corrective and preventive action and effectiveness, deal with customer complaint in time, continuous improve customer satisfactions.
? Lead Material Review Board (MRB) to dispose nonconforming material, identify the root cause and initiate corrective/preventive actions to eliminate defects. (e.g. Flow chart, 5 Why, Fish bone)
? Responsible of effective implementation of corrective and preventive action, advisory notice and adverse event report and continuous improvement.
? Accomplish responsible work per priority in a high quality and high efficiency manner, even under multi-task pre-condition.
? Continuous improve product quality and process.
? Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment. (e.g. Gage design, GR&R )
? Responsible for inspection method training, and standardize inspection method, come out with work instruction.
? Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s, Risk Reduction)
? Define process, product and test method validation requirements, preparation and approval of validation protocols and reports. (e.g. EIQ/EOQ/POQ/PPQ)
? Prepare weekly report\monthly report from raw material to finished goods full process quality per company and department target and come out with corrective preventive action, in order to meet target.
? Attend to maintain and monitor quality system running and organization, internal quality audit.
? Accomplish task assigned by leader.
? è² (fù)責(zé)新產(chÇŽn)å“質(zhì)é‡ç®¡ç†ç–劃, 確ä¿å…¶é†«(yÄ«)療器械法è¦(guÄ«)和體系的符åˆæ€§;
? è² (fù)責(zé)è€ç”¢(chÇŽn)å“çš„ç¶è·(hù)å’ŒæŒçºŒ(xù)改進(jìn)ï¼›
? è² (fù)責(zé)客訴的調(dià o)查ã€é¢¨(fÄ“ng)險(xiÇŽn)分æžã€ç³¾æ£å’Œé (yù)防措施åŠå…¶æœ‰æ•ˆæ€§, åŠæ™‚(shÃ)處ç†å®¢è¨´ï¼ŒæŒçºŒ(xù)æå‡å®¢æˆ¶æ»¿æ„度；
? è² (fù)責(zé)主導(dÇŽo)MRB物料評(pÃng)審委員會(huì)å°(duì)ä¸åˆæ ¼å“è©•(pÃng)審和處置，è˜(shÃ)åˆ¥æ ¹æœ¬åŽŸå› ï¼Œå•Ÿå‹•(dòng)ç³¾æ£/é (yù)防措施消除缺陷，如：æµç¨‹åœ–ã€5-為什么ã€éšéª¨åœ–。
? è² (fù)責(zé)ç³¾æ£é (yù)防措施有效實(shÃ)æ–½ã€å¿ 告性通知和ä¸è‰¯äº‹ä»¶å ±(bà o)å‘ŠåŠæŒçºŒ(xù)改進(jìn)工作；
? è² (fù)責(zé)在多任務(wù)çš„å‰æ下，按照優(yÅu)先級(jÃ)，高質(zhì)é‡å’Œé«˜æ•ˆçŽ‡åœ°å®Œæˆæœ¬è·å·¥ä½œï¼›
? æŒçºŒ(xù)改善產(chÇŽn)å“質(zhì)é‡å’Œæµç¨‹ï¼›
? è² (fù)責(zé)滿足程åºçš„檢驗(yà n)ã€è©¦é©—(yà n)方法的è¨(shè)計(jì)和開發(fÄ)，評(pÃng)估檢驗(yà n)ã€è©¦é©—(yà n)方法或產(chÇŽn)å“/éŽç¨‹/測(cè)試è¨(shè)備的精度è¦æ±‚ã€å¯é 性，如：檢具è¨(shè)計(jì)ã€MSA)ï¼›
? è² (fù)責(zé)培訓(xùn)檢驗(yà n)員檢驗(yà n)方法，并標(biÄo)準(zhÇ”n)化檢驗(yà n)方法，形æˆä½œæ¥(yè)指導(dÇŽo)書。
? 確ä¿éŽç¨‹æ‰€æœ‰è®Šé‡å’Œå½±éŸ¿å› ç´ è¢«å……åˆ†å®šç¾©ï¼Œç¢ºä¿æ‰€æœ‰çš„éŽç¨‹å¤±æ•ˆæ¨¡å¼è¢«å……分è˜(shÃ)別和解決，如：使用DOEç ”ç©¶ï¼ŒF(xià n)MEA，é™ä½Žé¢¨(fÄ“ng)險(xiÇŽn)：
? 確定éŽç¨‹ã€ç”¢(chÇŽn)å“和試驗(yà n)方法驗(yà n)è‰è¦æ±‚，準(zhÇ”n)備和批準(zhÇ”n)é©—(yà n)è‰æ–¹æ¡ˆå’Œå ±(bà o)å‘Š(e.g. EIQ/EOQ/POQ/PPQ)。
? æ ¹æ“š(jù)å…¬å¸æ•´é«”質(zhì)é‡ç›®æ¨™(biÄo)和部門目標(biÄo)，é‡å°(duì)原æ料至最終產(chÇŽn)å“å…¨éŽç¨‹è³ª(zhì)é‡çš„分æžå‘¨å ±(bà o)ã€æœˆå ±(bà o)，并形æˆå¿…è¦çš„ç³¾æ£é (yù)防措施，é”(dá)æˆç›®æ¨™(biÄo)ï¼›
? åƒèˆ‡ç¶è·(hù)ã€ç›£(jiÄn)ç£è³ª(zhì)é‡é«”系的é‹(yùn)è¡Œã€çµ„織和內(nèi)部質(zhì)é‡å¯©æ ¸å·¥ä½œï¼›
? 完æˆä¸Šç´š(jÃ)委派的其它任務(wù)。
ä»»è·è³‡æ ¼ Qualification
知è˜(shÃ)/教育程度 Knowledge / Education level
? Bachelor Degree，major in mechanical or engineering
? College degree, if with equivalent experience
? 本科å¸(xué)æ·ï¼Œæ©Ÿ(jÄ«)械ã€å·¥ç¨‹å°ˆæ¥(yè)，
? 大專å¸(xué)æ·ï¼Œè‹¥æœ‰ç›¸ç•¶(dÄng)資深的工作經(jÄ«ng)é©—(yà n)也å¯
經(jÄ«ng)é©—(yà n)/能力è¦æ±‚ Experience/Ability Requirement
? More than 2-3 years working experience in this position, working experience in medical device industry is preferred.
? Proficiency in AutoCAD, MS-office, statistical software, Minitab;
? Familiar with APQP, PPAP, MSA, quality control methods, statistical process control, 6-, Sigma
? ISO9001:2000, TS16949 internal auditor experience, ISO13485 internal auditor experience is preferred;
? With the quality system and CAPA system working experience.
? With ability to work independently and capable of working with a cross functional team.
? With multi-task experience
? With good skill of listen, written and oral English;
? 2-3 年以上本崗ä½å·¥ä½œç¶“(jÄ«ng)é©—(yà n)，有醫(yÄ«)療器械行æ¥(yè)工作經(jÄ«ng)é©—(yà n)為佳；
? 熟練使用AutoCAD，MS-office，統(tǒng)計(jì)軟件Minitab；
? 熟悉APQP, PPAP, MSA, 質(zhì)é‡æŽ§åˆ¶æ–¹æ³•, çµ±(tÇ’ng)計(jì)éŽç¨‹æŽ§åˆ¶ï¼Œ6- Sigma,
? ISO9001：2000，TS16949 å…§(nèi)審員經(jÄ«ng)é©—(yà n)，有ISO13485å…§(nèi)審員經(jÄ«ng)é©—(yà n)優(yÅu)先；
? 具備系統(tÇ’ng)的質(zhì)é‡é«”系和CAPA的工作經(jÄ«ng)é©—(yà n)
? å…·å‚™ç¨(dú)立工作能力并有和跨功能團(tuán)隊(duì)工作的能力
? 具備多任務(wù)的工作經(jīng)驗(yà n)
? 良好的英語è½èªªè®€å¯«èƒ½åŠ›;
