1.Principal Accountabilities (Major end results the job is expected to achieve)
主要工作职责（主要工作成就，期望此职位达到的目标）
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.
负责质量管理体系的维护，推动其持续提升。通过对质量相关数据的回顾分析，识别质量体系的缺失或提高机会，并促进其改善。
2)Lead quality reviews and analysis.
负责质量回顾和分析工作。
3)Lead the audit related activities (preparation, review, follow up), to make sure the high quality and response.
负责审核相关的工作（如准备，回顾及跟进），确保高质量和及时的回复。
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
针对于质量过程的落实情况和有效性，策划和实施一系列的验证核查工作（包括审核，检查，数据分析等），从而推进质量的持续提升。
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.
对于各流程提供质量体系要求方面的专业建议，从而保证其合规性和高质量。此外，负责苏州工厂设计质量保证流程。
6)Through deep involvement, to ensure the high quality of CAPA system, and high quality of each case investigation and
通过深度参与，保证NC和CAPA系统的高质量运行，以及保证事件调查和行动措施的高质量。
7)Support to continuously improve quality plan, to improve product quality assurance
协助持续改进质量计划，从而提升对于产品质量的保证。
8)Working on quality related trainings to enhance quality awareness for the site
致力于质量相关的培训，以提升质量意识。
9)From quality assurance aspect to support company projects, and ensure the compliance
从质量保证的角度对公司各项目提供支持，保证其合规性。

2.Job Context / Key Challenges
工作内容/主要的挑战
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.
主导对于质量管理体系相关的工作，能够通过各种分析敏捷地识别出体系的改进机会点，并在公司各部门有效推进其改善。有意识地运用各种分析及发起验证检查工作，以确保和推进体系的有效执行和持续提升。
2)Fully involving in CAPA cases, drive and gate-keeping the investigation depth and quality, to ensure the investigation and ’s effectiveness.
深度参与CAPA事件的调查工作，推进并确保其调查深度和质量，从而保证调查和行动对于事件解决的有效性。

3.Dimensions (Relevant facts and figures relating to job)
职责范围（与此职位相关的事务与指标）
1)Effectiveness of facilitating for QMS related activities (audit, management review, etc.).
有效推进各质量管理体系相关活动的进行（如审核，管理评审等）。
2)Initiate various review and analysis to drive system improvement.
发起各项回顾和分析，从而推进体系的提升。
3)Lead quality issue handling.
主导质量事件的处理。

4.Knowledge and Experience (Knowledge and experience needed for satisfactory performance of the job)
资质和经验（此职位所要求的资质和经验）
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年的质量体系或质量工程相关的工作经验。必须有丰富的质量管理体系知识和调查能力。医疗器械行业背景为佳。
2)Bachelor degree or above.
本科或以上学历。
3)Good English in reading, writing, listening and speaking.
优秀的英语读写听说能力。
4)Excellent team work and communication skills.
良好的团队和交流能力。
5)Good skills on planning, oriented, drive for results, and deep thinking. Can standing alone.
良好的工作计划能力，注重行动，结果导向，深入分析。能独立思考。