更新于 今天
职位描述
2. 策划并执行体系自查与预审核，提前梳理各部门文件资料及现场合规性，汇总问题点并推动责任部门整改；
3. 制定年度培训计划，组织员工开展体系文件、外来法规（如 ISO13485、MDR）培训，负责体系变更控制，跟踪关键岗位人员变更培训、技术要求变更审批，确保管理体系连续性；
4. 配合研发部完成产品注册体系考核，协调材料准备与节点跟踪；主导客户、第三方及国家监管机构审核，现场应答审核提问，汇总审核问题点并转化为内部预审核关注点，推动纠正预防措施落地；
5. 建立外来文件管理清单，定期跟踪法规及国家标准、行业标准的有效性，及时替换失效文件；
6. 分析外来文件与内部体系差异，将法规要求融入质量手册、程序文件中，完成有效转化；
7. 负责环境管理体系的法规收集、环境因素识别及运行检查，组织内审与管理评审，编制审核报告并推动不合格项整改，确保企业符合环保合规要求；
任职要求：
1. 本科及以上学历、有医疗行业相关工作经验，熟悉 ISO13485、GMP、MDR 等体系、具备良好的沟通协调能力，能够有效推动跨部门协作；
2. 能主导体系统审核、有一定管理能力、逻辑清晰，具备较强的问题分析与解决能力；
3. 工作细致严谨，有责任心，能按时完成任务；
4. 具备良好的学习能力，能快速适应新环境和新要求。
奖金绩效
工作地点
公司信息
公司介绍
常州乐奥医疗科技有限公司是海外归国人员创立的、致力于高端医疗器械研发、制造和销售的高科技中外合资企业。拥有具备国际视野和丰富医疗器械研发、生产、品质和销售经验的优秀团队，团队核心成员拥有多年在海外工作和国际国内领先企业从事研发、销售的经验。Leo Medical Co., Ltd. is a high-tech medical enterprise. We dedicate our work to research, develop, manufacture and market advanced medical devices. We have excellent teams of researchers, engineers, quality assurers and marketers. Many of them have extensive experience in their fields, and have collaborated with experts in various prestigious domestic and international institutions and companies in medical device development field.公司采用领先的生物医疗技术，服务于消化系统和血管循环系统疾病的诊断和治疗。公司目前已经研发的产品覆盖消化和血管介入治疗的微创医疗器械。公司秉承关注人、依赖人和服务人的理念，研发符合中国患者特点和中国医生使用习惯的医疗器械产品，为医生提供方便，为患者减轻病痛。Leo Medical utilizes leading biomedical technologies to develop medical devices for assisting the diagnosis, intervention and treatment of diseases in the digestive system and cardiovascular system. We believe in minimal invasive approach being the most human approach to the patients while not compromising the quality of the procedure. Minimal invasion in medical treatments often allow patients to recover quicker, and doctors to have simplify medical operation. It is a win-win approach for all. We stand by our believes and will continually devote our focus in this area.公司注重安全和质量，拥有符合国家质量体系标准的一万级净化车间和高品质的检测平台，确保每一件产品的质量。公司通过ISO13485质量体系认证，合乎国际质量管理体系要求。In addition to features, more importantly, we highly emphasis on safety and quality of our products. Our products are manufactured in 10,000 Class Clean Room (Equivalent to Grand B of ISO standards). We follow repeatable and practical SOPs for product testing online and offline. Leo Medical is accredited with ISO13485:2003 Certificate of Quality Management System and is in fully compliance with The Requirements of International Quality Management System.
