QMS Quality Engineer job opportunity at Danaher.

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DatePosted 30+ Days Ago bot
Danaher QMS Quality Engineer
Experience: General
Pattern: full-time
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degreeGeneral
loacation Suzhou, Jiangsu, China, China
loacation Suzhou, Jiangs..........China

本岗位的工作范围是确保建立、实施、保持 和提高质量管理体系，使公司体系符合医疗器械相关质量管理体系和法规要求。例如：中国GMP，ISO13485 等。 负责质量体系的日常工作，包含 负责公司质量管理体系维护，包括体系要求的满足、以及体系运行的监控。 跨部门合作，推进医疗器械法规和GMP要求在公司的执行。 主导雷度苏州的流程优化，能够持续保持与总部要求一致。 负责公司质量管理体系的管理评审、内外部审核、日常监督检查，跟踪审核发现项、建议项、改进项的整改和纠正/预防措施的落实。 主要职责： 协助建立、维护和持续改进公司质量管理体系，保证质量体系有效运行。 创建并维护质量体系文件以支持业务需求，并符合标准和法规要求。 定期组织质量体系内部审核，以及内部审核发现项的整改跟踪，确保相关整改措施及时关闭。 协助完成管理评审会议，以及管理评审措施跟踪。 负责并协调外部审核的准备，执行及后续审核发现项的跟踪，确保相关整改措施及时关闭。 参与法律法规的评审，协助识别适用的法律法规，必要时将法规要求转为公司内部的质量管理体系流程。 负责公司质量体系流程优化和改进工作。 负责质量体系相关的培训，提升公司员工的质量意识。 负责工厂CAPA系统的维护，组织CAPA会议，推动和跟进CAPA直至结束，确保CAPA流程持续合规。 负责文件和记录控制。 与现场流程负责人合作，定义流程和系统改进，实现“持续改进”的价值。 以高效专业的方式与各部门在各个层次上进行沟通，以满足质量体系的要求 根据要求协助所有现场质量体系项目，积极参与团队工作以实现公司质量目标。 完成上级安排的其他工作。 Join our winning team today. Together, we’ll 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. For more information, visit www.danaher.com .

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