QMS Engineer

• Establish, maintain and continual improve QMS, including monitor QMS process effectiveness and performance with data analysis.

建立、维护和持续改进公司质量管理体系，包括通过数据分析监控质量管理体系实施有效性及运行情况。

• Responsible for QMS training and document control management.

负责质量管理体系（QMS）培训及文件控制管理工作。

• Lead internal and external audit according to ISO9001, ISO13485, FDA 21 CFR Part 820 or China NPMA

• , to identify QMS gap and work closely with stakeholders to close gaps.

根据 ISO9001、ISO13485、FDA 21 CFR Part 820 及中国 NMPA 等要求，负责主导内外部审核，识别质量管理体系（QMS）差距，并与相关利益相关方紧密合作，推动差距整改与有效关闭。

• Closely collaborate with cross functional process owners to work on quality process improvements and facilitate site CAPA in supporting for root cause investigation, solution implementation, and the verification of the CAPA effectiveness.

与跨职能流程负责人紧密合作, 推动质量流程改进, 并促进工厂CAPA的实施, 支持根因分析,解决方案执行及CAPA有效性的验证。

• Responsible for implementing and maintaining site eQMS system, and ensure QMS KPI and metrices are updated regularly and escalate for continual improvements, and participating in Global Quality Management Review meetings.

负责实施和维护工厂电子质量管理系统（eQMS），确保质量管理体系（QMS）关键绩效指标（KPI）及相关指标定期更新，并推动问题升级以实现持续改进，同时参与全球质量管理评审会议。

• Any agreed-to works by superiors.

上级安排其它的工作

• Diploma or degree in any Engineering related field or any relevant QMS or Quality Assurance with 3-5 years experience in manufacturing quality.

工程相关领域的大专或本科学历，具备相关质量体系或质量保证及 3-5 年制造质量经验。 

• Experience in conducting/leading QMS audits.

具备开展/主导质量管理体系（QMS）审核的经验。

• Excellent writing and oral communication skills with the ability to effectively interface with a variety of associates at various levels.

具备优秀的书面及口头沟通能力，能够与不同层级的员工进行有效沟通与协作。

• Organized and detail-oriented with a high level of initiative, self-motivation and energy

做事有条理、注重细节，并具备高度主动性、自我驱动力和充沛精力。

• Ability to travel –5% travel, overnight, within territory (if necessary) or occasional international travel to Singapore. 能够接受约5%的出差, (如有需要) 包括区域内的过夜出差, 或偶尔前往新加坡的国际出差.

• It would be a plus if you also possess previous experience in: 如果您还具备以下经验将更具优势：
  • Experience in ISO9001 or, ISO13485, or China NMPA manufacturing environment 具备在ISO9001或ISO13485 或中国NMPA体系下的制造环境工作经验
  • Experience in managing Documentation Control and establishing QMS processes. 具有文件/文档控制管理及建立质量管理体系（QMS）流程的经验.
  • Knowledge in the Microsoft (Word, Excel) applications.具备微软 文档, Excel 应用的相关知识