北京招聘

职位描述：
Purpose of the Job
Play as the leading role to continuously improve the Quality Management System (QMS) and ensure the effective implementation of QMS. Maintain the effectiveness of Medical Device Production License, Medical Device Sales License and ISO 13485/9001 certificates
领导公司持续改进质量管理体系，确保质量管理体系的有效实施；保证《医疗器械生产许可证》、《医疗器械经营许可证/备案》和ISO 13485/9001证书的有效性。
Monitor QMS related regulations/standards to ensure the compliance in time.
 监控QMS相关法规/标准，并确保及时实施；
Apply / update Medical Device Production License and Medical Device Sales Licenses as business needs
根据业务需求申请并更新《医疗器械生产许可证》和《医疗器械经营许可证/备案》；
Lead the company to pass the certification audit and annual surveillance audit of ISO 13485 / 9001 certificate.
 带领公司通过ISO 13485 / 9001认证审核及年度审核；
Take lead in passing the QMS audit for new product homologation , extended / change product homologation and any announced or unannounced authority inspection.
主导通过新产品注册、延续注册、变更注册相关QMS审核及其它通知或未通知的官方检查；
Organize the internal audit, external audit and management review meeting. Coordinate the appropriate follow-up actions for the findings from the audits and management review.
组织内部、外部审核及管理评审会议。协调审核及管理评审会议中发现的整改措施；
Take charge of documents control involving collecting and releasing for all QMS documents.
负责文档管控，包括收集和发行所有QMS文件；
CAPA follow-up 跟进CAPA；
Monitor and handle the adverse events according to China Medical Device regulation an global policy.
根据中国医疗器械法规及全球政策要求监控并处理不良事件
Act as the main role for duly responding to the post-market surveillance
在市场监管处理团队中充当核心成员；
Proofread the User Guide and Label to ensure the compliance of the regulation.
说明书和标签校对，以确保法规符合性；
Collect the data relating to medical device production and sales required by government and submit in a timely manner.
根据政府要求收集医疗器械生产和经营有关数据并及时提交；
Performs other duties as required by Manager. 完成上级交付的其他任务。

Bachelor or above, Engineering, Electronics, Biology, Pharmacy, Medical Science relevant professional.
工程、电子、生物、医学、制药相关专业本科及以上学历
 At least 5 years working experience in MDD quality system.
5年以上医疗器械质量管理体系工作经验
- Comprehensive knowledge in Medical Device Regulation and relevant National / Industrial standards.
医疗器械法规及相关国家/行业标准知识丰富
- Proven experience in FDA’s inspection as well as ISO 9001 & ISO 13485 certification/surveillance audit.
具有中国药监局现场审核及ISO 9001 / 13485认证/年度审核经验
 Strong willingness of team work
团队合作
- Careful and high responsibility
工作稳重细心，有较强的责任心
- flexibility
灵活
- Ability to work under pressure，stress resistance
能在压力下工作，具有一定的压力调节能力
Good English communication skill in reading, speaking and writing
良好的英语沟通能力
Microsoft Office
熟练使用Microsoft Office软件 举报 分享

总部位于瑞士施泰法的索诺瓦集团是全球知名的听力保健解决方案供应商。集团通过其核心业务品牌峰力、 优利康、汉莎通,领先仿生 和 AudioNova 开展运营。 索诺瓦集团为其客户提供行业内全面的产品组合,从听力设备到人工耳蜗，再到无线通讯解决方案。
集团创立于 1947 年，业务遍布全球 100 多个国家，有超过 14,000 名高度敬业的员工。
索诺瓦集团 2018/19 财年的销售额达 27.6 亿瑞士法郎，净利润达 4.602 亿瑞士法郎。无论是所有业务的开展，还是对聆听世界基金会的支持， 索诺瓦集团展望一个大家都能享受聆听，从而实现人生所想的世界。

 Sonova, headquartered in St？fa, Switzerland, is a leading provider of innovative hearing care solutions. The group operates through its core business brands？Phonak, Unitron,？Hansaton,？Advanced Bionics？and？AudioNova. We reach our consumers through multiple channels; this diversity lets them benefit from our broad range of solutions – hearing aids, cochlear implants, wireless communication products, digital solutions, and professional audiological care – in the way that best suits their individual needs. Founded in 1947, the group is currently present in over 100 countries across the globe, has a workforce of over 15,000 dedicated employees and generated sales of CHF 2.92 billion in the financial year 2019/20 as well as a net profit of CHF 490 million.. Across all businesses Sonova pursues its vision of a world where everyone enjoys the delight of hearing and therefore lives a life without limitations.