| Job Description
1. Be responsible for process validation. 负责过程确认 2. Be responsible for preparing, revising and reviewing quality management system documents. 负责质量体系文件的编制、修订和评审 3. Organize internal QMS audit and ensure corrective and preventive actions to be taken. 组织质量体系内审并确保纠正预防措施的采取 4. Coordinate external audits from BSi, FDA and SFDA. 协调BSi，FDA和SFDA审核 5. Be responsible for related regulatory activities and make sure product sale can comply with laws and regulations. 负责相关法规活动，并确保产品销售符合法律法规要求 6. Be responsible for CAPA management and for trend analysis to data from various sources. 负责CAPA管理，并对各种来源的数据进行趋势分析 7. Be responsible for effective delivery and handling of complaints. 负责对报怨的有效传递和处理 8. Grasp current status of regulations related to medical devices on time and publicize within company. 及时掌握与医疗器械相关的最新法规状态，并在公司内进行宣传 9. Take part in risk management activities. 参与风险管理活动 Qualification 1. College degree above, major in machinery or biology or related. 大专以上学历，机械、生物或相关专业 2. At least 5 years of working experience in quality assurance or regulatory compliance department. 至少5年以上品保或法规工作经验 3. Good English both in speaking and writing. 英语读说写流利 4. Be familiar with ISO9001:2000 quality management system. 熟悉ISO9001:2000质量管理体系 5. Own experience of establishing and maintaining of quality management system. 具有质量管理体系建立和维护经验 6. Strong communication skill，be patient and persistent. 善于沟通, 有耐心和恒心 If you are interested in this job, please be free to contact us by staffing@biomet.com.cn |
