品质助理工程师Assistant QA Engineer

岗位职责Job Responsibility：1.Support to valid and track CAPA effectiveness 协助QA 对CAPA有效性的验证及跟踪 2. Suppot to implement and maintain NMPA and QMS related paperwork 协助QA 做相关的NMPA 推行及维护, 及QMS的相关的文书工作 3. Support to improve and follow up the quality project, organize and make the corresponding corrective action, track and verify its effectiveness 协助QA对品质专案的改进与跟踪，组织并制定相应的纠正措施，跟踪验证其有效性4. Suppor to do internal and external audit of ISO9001&ISO13485 system and follow up the unqualified item and implement NMPA 协助QA做ISO9001&ISO13485 体系内外审及不合格项追踪和推行NMPA. 5. Advance quality planning of medical products and follow-up of improvement measures医疗产品的先期品质策划及改善措施的跟进6. Support to collect statistic related quality data and determine improvement direction协助收集统计相关的品质数据,确定改善的方向7. Support to make advance quality plan and FMEA for new products.协助QA做新产品的先期品质计划及FMEA.8. Support to regularly audit medical product manufacturing process compliance and re-evaluate product risk协助对医疗产品制程合规性的定期审核及产品风险的再评估 任职资格Job qualification： 1. College degree or above in product quality Engineering, biomedical engineering or related major; Basic English, good at reading and writing大专以上学历，产品质量工程、生物医学工程或相关专业，有一定英语基础，读写良好2. be Familiar with ISO13485 , GMP and internal auditor qualification certificate for pirority.熟悉 ISO13485、GMP 等质量管理体系，有内部审核员资格证优先 3. Have the quality control management experience in medical device manufacturer prefer有医疗器械制造 的质量控制管理经验者佳。 4. Skilled in quality tools, such as quality 7 tools, MSA, FMEA, SPC, CP, 8D, 5WHY, fish bone diagram, etc., familiar with problem processing process。熟练使用质量工具，如质量7个工具, MSA, FMEA, SPC, CP, 8D, 5WHY, fish bone diagram等，熟悉问题处理流程。5. Be interesting in office copy and documents management.对办公室文案和文件管理有兴趣 【联系我时，请说是在 【聘聘】微信小程序上看到的，谢谢！】 注：本站相关图片或视频等素材、信息，由相应企业提供及上传，如有争议请联络本站客服删除。