1.Principal Accountabilities (Major end results the job is expected to achieve)
主要工作職責(zé)（主要工作成就，期望此職位達(dá)到的目標(biāo)）
1)Lead the maintaining of QMS, and drive the continuous improvement. Identify quality system opportunity/gap by reviewing all quality data, and lead for improvement.
負(fù)責(zé)質(zhì)量管理體系的維護(hù)，推動(dòng)其持續(xù)提升。通過對質(zhì)量相關(guān)數(shù)據(jù)的回顧分析，識別質(zhì)量體系的缺失或提高機(jī)會(huì)，并促進(jìn)其改善。
2)Lead quality reviews and analysis.
負(fù)責(zé)質(zhì)量回顧和分析工作。
3)Lead the audit related activities (preparation, review, follow up), to make sure the high quality and response.
負(fù)責(zé)審核相關(guān)的工作（如準(zhǔn)備，回顧及跟進(jìn)），確保高質(zhì)量和及時(shí)的回復(fù)。
4)Plan and conduct a series of verifications for quality processes execution and effectiveness (audit/inspection/data analysis, etc.), and drive for the quality continuous improvement
針對于質(zhì)量過程的落實(shí)情況和有效性，策劃和實(shí)施一系列的驗(yàn)證核查工作（包括審核，檢查，數(shù)據(jù)分析等），從而推進(jìn)質(zhì)量的持續(xù)提升。
5)Giving suggestions to support other process owners to match QMS requirements in a high quality way. Acting as Design QA process owner of site.
對于各流程提供質(zhì)量體系要求方面的專業(yè)建議，從而保證其合規(guī)性和高質(zhì)量。此外，負(fù)責(zé)蘇州工廠設(shè)計(jì)質(zhì)量保證流程。
6)Through deep involvement, to ensure the high quality of CAPA system, and high quality of each case investigation and
通過深度參與，保證NC和CAPA系統(tǒng)的高質(zhì)量運(yùn)行，以及保證事件調(diào)查和行動(dòng)措施的高質(zhì)量。
7)Support to continuously improve quality plan, to improve product quality assurance
協(xié)助持續(xù)改進(jìn)質(zhì)量計(jì)劃，從而提升對于產(chǎn)品質(zhì)量的保證。
8)Working on quality related trainings to enhance quality awareness for the site
致力于質(zhì)量相關(guān)的培訓(xùn)，以提升質(zhì)量意識。
9)From quality assurance aspect to support company projects, and ensure the compliance
從質(zhì)量保證的角度對公司各項(xiàng)目提供支持，保證其合規(guī)性。

2.Job Context / Key Challenges
工作內(nèi)容/主要的挑戰(zhàn)
1)Taking the leading role to manage the QMS related works, have the agility to identify system improvement opportunities and drive the improvement accordingly. Intentionally initiate analysis and verifications to ensure the system’s execution and continuous improvement.
主導(dǎo)對于質(zhì)量管理體系相關(guān)的工作，能夠通過各種分析敏捷地識別出體系的改進(jìn)機(jī)會(huì)點(diǎn)，并在公司各部門有效推進(jìn)其改善。有意識地運(yùn)用各種分析及發(fā)起驗(yàn)證檢查工作，以確保和推進(jìn)體系的有效執(zhí)行和持續(xù)提升。
2)Fully involving in CAPA cases, drive and gate-keeping the investigation depth and quality, to ensure the investigation and ’s effectiveness.
深度參與CAPA事件的調(diào)查工作，推進(jìn)并確保其調(diào)查深度和質(zhì)量，從而保證調(diào)查和行動(dòng)對于事件解決的有效性。

3.Dimensions (Relevant facts and figures relating to job)
職責(zé)范圍（與此職位相關(guān)的事務(wù)與指標(biāo)）
1)Effectiveness of facilitating for QMS related activities (audit, management review, etc.).
有效推進(jìn)各質(zhì)量管理體系相關(guān)活動(dòng)的進(jìn)行（如審核，管理評審等）。
2)Initiate various review and analysis to drive system improvement.
發(fā)起各項(xiàng)回顧和分析，從而推進(jìn)體系的提升。
3)Lead quality issue handling.
主導(dǎo)質(zhì)量事件的處理。

4.Knowledge and Experience (Knowledge and experience needed for satisfactory performance of the job)
資質(zhì)和經(jīng)驗(yàn)（此職位所要求的資質(zhì)和經(jīng)驗(yàn)）
1)A minimum of 3 years’ experience in Quality System or Quality Engineering related works. Strong knowledge and skill in QMS and Non-conformance investigation. Medical Device industry is a plus.
至少3年的質(zhì)量體系或質(zhì)量工程相關(guān)的工作經(jīng)驗(yàn)。必須有豐富的質(zhì)量管理體系知識和調(diào)查能力。醫(yī)療器械行業(yè)背景為佳。
2)Bachelor degree or above.
本科或以上學(xué)歷。
3)Good English in reading, writing, listening and speaking.
優(yōu)秀的英語讀寫聽說能力。
4)Excellent team work and communication skills.
良好的團(tuán)隊(duì)和交流能力。
5)Good skills on planning, oriented, drive for results, and deep thinking. Can standing alone.
良好的工作計(jì)劃能力，注重行動(dòng)，結(jié)果導(dǎo)向，深入分析。能獨(dú)立思考。