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2020-09-16发布

招聘人数:1&/Job/JobDetail/x4EBA;

10-15K

申请职位

职位信息

必须具有IVD行业经验 1. 规划和建立公司质量管理体系和管理制度,并监督执行; 2. 负责研发及生产过程中的质量管理和控制,健全质量考评体系,推行全面质量管理,宣贯培训医疗器械研发生产法规要求,不断提高产品质量及合规性; 3. 负责供应商质量管理体系的评定、审核和再评价; 4. 组织编写公司质量管理体系文件,起草并执行年度质量目标; 5. 负责出具不合格品处理意见的最终审批; 6. 负责计量器具年度外校计划的批准; 7. 负责制定年度医疗器械新产品认证和注册计划的制定; 8. 负责纠正预防措施计划和验收结果的批准; 9. 负责质量管理体系、产品的注册、认证工作安排; 10. 负责医疗器械行业内法律法规的宣贯和内部培训组织,参与新项目开发过程中的法规评审和需求确认。 任职资格: 1、医疗器械/生物工程/质量管理相关专业本科及以上学历,3年以上三类医疗器械/IVD体外诊断试剂行业质量管理工作经验; 2、参加过质量管理体系内审员培训(ISO9001、ISO13485、TS16949等),具备质量管理体系(ISO9001、ISO13485、TS16949等)知识、统计学基础知识; 3、熟悉IVD质量管理或医疗器械质量管理; 4、熟悉国内医疗器械相关法规,医疗器械通用安全标准知识,有三类医疗器械注册经验优先; 5、掌握应用文写作知识,擅长文档编写,能快速理解并应用相关法规制度; 6、具有极强的责任心和敬业精神,良好的沟通和表达能力,灵活,能随机应变;良好的抗压能力,擅于人际交往,具备良好的合作精神和团队管理经验;优秀的外联和公关能力,具备解决突发事件能力。

联系方式

上班地址:芙蓉花路500弄1号楼4楼

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奥然生物科技(上海)有限公司成立于2015年03月04日,注册地位于上海市浦东新区广丹路222弄12号一层
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