1.Principal Accountabilities (Major end results the job is expected to achieve)
主要工作職責（主要工作成就，期望此職位達到的目標）
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.
負責質量管理體系的維護，推動其持續提升。通過對質量相關數據的回顧分析，識別質量體系的缺失或提高機會，并促進其改善。
2)Lead quality reviews and analysis.
負責質量回顧和分析工作。
3)Lead the audit related activities (preparation, review, follow up), to make sure the high quality and response.
負責審核相關的工作（如準備，回顧及跟進），確保高質量和及時的回復。
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
針對于質量過程的落實情況和有效性，策劃和實施一系列的驗證核查工作（包括審核，檢查，數據分析等），從而推進質量的持續提升。
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.
對于各流程提供質量體系要求方面的專業建議，從而保證其合規性和高質量。此外，負責蘇州工廠設計質量保證流程。
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系統的高質量運行，以及保證事件調查和行動措施的高質量。
7)Support to continuously improve quality plan, to improve product quality assurance
協助持續改進質量計劃，從而提升對于產品質量的保證。
8)Working on quality related trainings to enhance quality awareness for the site
致力于質量相關的培訓，以提升質量意識。
9)From quality assurance aspect to support company projects, and ensure the compliance
從質量保證的角度對公司各項目提供支持，保證其合規性。

2.Job Context / Key Challenges
工作內容/主要的挑戰
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.
主導對于質量管理體系相關的工作，能夠通過各種分析敏捷地識別出體系的改進機會點，并在公司各部門有效推進其改善。有意識地運用各種分析及發起驗證檢查工作，以確保和推進體系的有效執行和持續提升。
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事件的調查工作，推進并確保其調查深度和質量，從而保證調查和行動對于事件解決的有效性。

3.Dimensions (Relevant facts and figures relating to job)
職責范圍（與此職位相關的事務與指標）
1)Effectiveness of facilitating for QMS related activities (audit, management review, etc.).
有效推進各質量管理體系相關活動的進行（如審核，管理評審等）。
2)Initiate various review and analysis to drive system improvement.
發起各項回顧和分析，從而推進體系的提升。
3)Lead quality issue handling.
主導質量事件的處理。

4.Knowledge and Experience (Knowledge and experience needed for satisfactory performance of the job)
資質和經驗（此職位所要求的資質和經驗）
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年的質量體系或質量工程相關的工作經驗。必須有豐富的質量管理體系知識和調查能力。醫療器械行業背景為佳。
2)Bachelor degree or above.
本科或以上學歷。
3)Good English in reading, writing, listening and speaking.
優秀的英語讀寫聽說能力。
4)Excellent team work and communication skills.
良好的團隊和交流能力。
5)Good skills on planning, oriented, drive for results, and deep thinking. Can standing alone.
良好的工作計劃能力，注重行動，結果導向，深入分析。能獨立思考。