品质工程师QA Engineer（体系）

岗位职责JobResponsibility：1.SupporttovalidandtrackCAPAeffectiveness协助QA对CAPA有效性的验证及跟踪2.SuppottoimplementandmaintainNMPAandQMSrelatedpaperwork协助QA做相关的NMPA推行及维护,及QMS的相关的文书工作3.Supporttoimproveandfollowupthequalityproject,organizeandmakethecorrespondingcorrectiveaction,trackandverifyitseffectiveness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.SupportodointernalandexternalauditofISO9001&ISO13485systemandfollowuptheunqualifieditemandimplementNMPA协助QA做ISO9001&ISO13485体系内外审及不合格项追踪和推行NMPA.5.Advancequalityplanningofmedicalproductsandfollow-upofimprovementmeasures医疗产品的先期品质策划及改善措施的跟进6.Supporttocollectstatisticrelatedqualitydataanddetermineimprovementdirection协助收集统计相关的品质数据,确定改善的方向7.SupporttomakeadvancequalityplanandFMEAfornewproducts.协助QA做新产品的先期品质计划及FMEA.8.Supporttoregularlyauditmedicalproductmanufacturingprocesscomplianceandre-evaluateproductrisk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Jobqualification：1.CollegedegreeoraboveinproductqualityEngineering,biomedicalengineeringorrelatedmajor;BasicEnglish,goodatreadingandwriting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.beFamiliarwithISO13485,GMPandinternalauditorqualificationcertificateforpirority.熟悉ISO13485、GMP等质量管理体系，有内部审核员资格证优先3.Havethequalitycontrolmanagementexperienceinmedicaldevicemanufacturerprefer有医疗器械制造的质量控制管理经验者佳。4.Skilledinqualitytools,suchasquality7tools,MSA,FMEA,SPC,CP,8D,5WHY,fishbonediagram,etc.,familiarwithproblemprocessingprocess。熟练使用质量工具，如质量7个工具,MSA,FMEA,SPC,CP,8D,5WHY,fishbonediagram等，熟悉问题处理流程。
5.Beinterestinginofficecopyanddocumentsmanagement.对办公室文案和文件管理有兴趣