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QMS工程师
2023.11.11

工作职责:
1、负责公司质量管理体系维护,包括体系要求的满足、整体策划以及体系运行的监控,特别是研发产品的质量管理体系维护。
2、负责外部审核前的准备和审核现场的协调,负责推动审核问题的整改与跟踪,确保审核问题及时有效关闭,公司顺利通过各种体系审核。
3、组织内部审核和产品GMP自查、日常巡检等工作,对发现的问题进行推进和跟踪。
4、负责质量体系变更的协调和外部申报工作,确保变更有序可控。
5、负责协调与其他部门的业务关系及上级指派的其他任务。


岗位要求:
1、本科及以上学历,医疗器械、机械、电子、生物、化学、医学、药学、微生物、质量管理等相关专业;
2、质量体系相关工作经验3年以上,有接受现场审核经验优先,有研发产品质量管理经验优先;
3、熟悉ISO13485、QSR820、MDR和GMP相关法规、标准要求;英语听、说、读、写熟练者优先;
4、对工作认真仔细、有高度的责任心,具有一定的部门沟通协调能力;有团队合作精神、服务意识;
5、有内审员证书优先。

Please submit your resume to:xtzhaopin@microport.com
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