Sr. QMS Engineer 高级体系工程师

该职位来源于猎聘 职位概要(Job summary):维护并完善公司的质量管理体系，贯彻执行体系和法规，确保公司的质量管理体系符合法规和客户的要求。 Maintain and improve Quality Management System in Quasar, implement system and regulation internally, and ensure QMS fulfill regulatory and customer requirements. 工作职责(Responsibilities): 1. 维护并完善公司的质量管理体系，与各部门一起完善QMS文件的制定与修改； Maintain and improve company Quality Management System, work together with each department to create and update QMS documents; 2. 日常质量管理体系运行的监督，改善的建议与跟踪，维护质量目标、关键绩效指标（KPI）和质量指标，以监控质量管理体系的有效性； Monitor QMS implementation status, propose improvement activities and follow up the status, maintain quality objectives, key performance indicators (KPIs), and Quality Metrics to monitor the effectiveness of the QMS; 3. 编写、指导和监督CAPA和客诉，实施有效性确认直至关闭； Create, guide and monitor CAPAs and customer complaint, perform effectiveness check until closure; 4. 主导总部审核和法规检查及客户审核，以评估合规性并识别改进区域； Lead corporate audits, regulatory inspections and customer audits to assess compliance and identify areas for improvement; 5. 主导和推进管理评审会议，以评估质量管理体系的运行情况并推动持续改进措施； Lead and facilitate Management Review meetings to evaluate the performance of the QMS and drive continuous improvement initiatives; 6. 随时了解与医疗器械相关的法规、标准和最佳实践的变化，并对质量管理体系进行必要的更新； Stay informed about changes in regulations, standards, and best practices relevant to medical devices, and implement necessary updates to the QMS; 7. 为人员提供质量相关主题的培训和支持，包括质量管理体系程序、法规和合规要求；在整个组织内推动质量和合规文化，提高质量在所有活动中重要性的认识和理解； Provide training and support to employees on quality-related topics, including QMS procedures, regulations, and compliance requirements; Drive a culture of quality and compliance throughout the organization, promoting awareness and understanding of the importance of quality in all activities; 8. 维护产品认证、体系认证证书以及内审员的评定及培训； Maintain product certificate and QMS certificates, internal auditor assessment and training; 9. 完成FDA要求的相关活动，确保质量管理体系满足QMSR的要求并确保其持续的适宜性，充分性和有效性，有问题随时汇报和反馈； Complete the FDA required related activities to ensure the QMS meet QMSR requirements, and ensure its continuing suitability, adequacy and effectiveness; 10. 处理上级交办的其他事宜。 Deal with other tasks assigned by superiors. 任职资格(Qualification): 1. 本科以上学历； Bachelor degree or above. 2. 5年以上相关工作经验； Above 5 years relative work experience. 3. 英语读写能力，CET-4合格或以上； Proficiency in written and reading English, passed CET-4 or above. 4. 具备良好的沟通能力和逻辑思维能力； Proven communication skills and logical thinking; 5. 踏实肯干，善于学习。

Diligent and hardworking, with a strong learning ability.