岗位职责 负责质量体系文件管理，维护和改进，并满足中国法规和梅里埃相关要求 Responsible for quality document management system establish, maintain and improvement , to ensure compliance status to China regulation and BMX requirements 把分配到的工作进行组织和协调。 Organize and coordinate the assigned work 质量管理体积建立维护和改进/QMS Establishment, maintain and improvement 负责组织并维护工厂质量管理体系文件的运行，使用企业内部文档控制系统进行文件生效、分发、回收归档及作废，周期性文件审核等文件管理工作。 Organizing and maintaining the operation of site quality management system documents, using the internal document control electronic system to carry out document management, such as effective, distribution, archiving and obsolete, and periodic document review. Maintain logbook management，including subscription, distribution and archive; 支持电子培训系统使用，包括培训数据分析，定期更新培训矩阵。 Support E-Qualification using，including analysis training data, update training matrix periodically 审核/ Audit Program 支持与参与体系审计和自查（例如迎审准备等工作）。 Support and participate in QMS audit and self-inspection (e.g. preparation for audit).。 其他/Others 负责质量体系专用章管理（验证章、受控章等）。 Maintain quality system special seal management (verification seal, controlled seal, etc.). 参与质量文化建设，例如质量文化周，质量培训 Participate in quality culture building, e.g. quality c 岗位要求 大专及以上学历，生物，化学，医学相关专业或工作经验 语言技能：英语读写 熟悉ISO9001 & 13485 &GMP等医疗器械及体外诊断试剂相关法规经验 Familiar with ISO9001& 13485 &GMP, and other Medical Device or IVD related regulations 熟练的office办公软件的操作 Skilled with Microsoft office 有良好的团队合作能力 Good Interpersonal skill and team player .