- 协助质量负责人进行质量管理体系的建立、运行、维护和持续改进。
- 协助制订质量管理制度,监督制度的执行,并对质量管理制度的执行情况进行检查、纠正和持续改进。
- 负责收集与医疗器械经营相关的法律、法规等有关规定,实施动态管理;
- 督促相关部门和岗位人员执行医疗器械的法规规章;
- 协同相关部门对医疗器械供货者、产品、购货者资质的审核;
- 负责医疗器械不良事件的收集与报告;
- 负责医疗器械召回的管理;
- 组织或者协助开展质量管理培训;
- 参与公司内部审核;
- 负责公司经营许可证的办理、更新及变更;
- 负责医疗器械质量投诉和质量事故的调查、处理及报告;
- 组织或协助对第三方物流公司的质量保障能力的审核;
- 负责MAPSS(市场、广告、推广、科学和销售)资料的审核
- 负责医疗器械广告的审批
- 其他质量经理要求的相关事务
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Senior Quality Specialist - Shanghai, 中国 - Danaher Corporation
描述
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
