Areas of Responsibilties: 1. CAPA Representative / CAPA代表 1) Develop, establish, maintain and optimize a CAPA process together with the process owner, including required certifications based on internal and external quality regulatory related requirements and in alignment with the Siemens Healthineers Process Framework. /与流程负责人一起开发，建立和维护，并优化统一的CAPA流程，满足包括内部和外部质量法规认证的要求及符合西门子医疗流程框架。 2) Has an overall view of all CAPA sources and monitor escalated topics./了解所有CAPA数据来源并监控升级的问题。 --Regularly report the CAPA status to the management/定期报告CAPA管理现况 --Regular internal assessments for CAPA process based on Siemens Healthineers quality management guidelines. Direct report to the CQI team leader with recommendation of improvement actions and their follow up controlling./根据西门子医疗质量管理指南对CAPA流程进行例行的内部评估，并直接向持续质量改进主管汇报改进建议及改进措施跟踪情况. 3) Train CAPA and problem solving mindset, knowledge and tools to related persons to facilitate CAPA process smoothly./向相关的人员培训CAPA和解决问题的意识，知识和工具以使开展CAPA更畅顺。 -- Work together with process owner for the CAPA/和流程负责人一起制定纠正预防措施 -- Verify the CAPA for the non-compliance findings./验证不符合项的纠正预防措施 2. Internal auditor/内审员 1) Check whether SSMR-MR quality regulations are compliance with the standards, regulations and Siemens Healthineers QRs./检查SSMR-MR的质量程序是否符合相关标准,法规和西门子医疗质量规定. 2) Performed the audits as planed to check whether the SSMR-MR quality regulations are followed effectively/按计划执行内审,检查SSMR-MR质量规定是否有效地实施. 3. Statistical technique application/统计技术应用 1) Establish, maintain and optimize statistical technique application process and ensure the process and implementation comply with regulation requirements./建立、维护和优化统计技术应用流程，确保流程和实施符合法规要求。 Education and Experience: -Bachelor degree on Engineering, or other relevant qualification. 工程或其他相关专业本科学历 -At least 5 years experience for quality management 5年及以上质量管理经验 -Profess. Know.: Fluent in English (spoken and written)/流利的英文（听说读写） -Medical device product knowledge/医疗器械产品知识 -Procedure