产品质量助理岗位职责

产品质量监控助理通用电气通用电气(中国)有限公司,GE,GENERALELECTRIC,通用电气,通用电气中国RoleSummary/Purpose:

Thisrolecombinesskillsinpostmarketregulation,statistics,andproductknowledgeintheprocessoftrendingandhandlingofincomingcomplaints.Thisrolewillfacilitatecommunication,clarify,anddrivethetimelyinvestigationofadverseevents.

EssentialResponsibilities:

1.Keycontributoraspartofacomplainthandlingunit2.Clarifyanddrivetimelyinvestigationofadverseeventsbyfacilitatingtranslationandcommunication.3Coordinateinquiriesfromregulatoryauthorities.4.EngagingproductdesignownerstodetermineeffectiveCAPA5.Identifyingcomplaintsthatrepresentfurtherevaluationunder21CFRPart803(MDR)6.Reviewingappropriatecriteriaforclosureofcomplaints7.Owningandcommunicatingmetricsonstatus8.Continuouslyworkingtoimprovetheprocess

Qualifications/Requirements:

1.Bachelorsdegreeinengineeringorhealthsciencesfield;oraHighSchooldiploma/GEDandminimum2yearsworkexperienceinaQualityorRegulatoryAssurancerelatedfield

DesiredCharacteristics:

1.Minimum1yearexperienceinmedicaldeviceorpharmaceuticalindustryinanEngineering,QualityorRegulatoryrelatedrole2.Product-specificknowledge3.Demonstratedknowledgeof21CFRPart8204.AbilitytodemonstrateGEHCGrowthValues5.Demonstratedexperienceprioritizingconflictingdemandsinanextremelyfastpacedenvironment6.Abilitytoworkindependently&inateamsetting7.Excellentverbal,written,andpresentationskillswiththeabilitytocommunicatebusinessissuesclearlyinEnglish&Mandarin(andwhereappropriate,beabletocommunicateinthelocallanguageverballyandinwriting).8.Excellentinterpersonal,organizational,andinfluencingskills9.Familiaritywiththeapplicationofmedicaldeviceasitrelatestopatientsafety10.Abilitytoanalyzeandprocessdata,anddrawtheappropriateconclusions11.Experienceworkingwithcross-functionalteamsandfacilitatingteamstoidentifyandimplementsolutionstocomplexproblems12.Abilitytoanalyzeandprocessdata,anddrawtheappropriateconclusions13.Experienceworkingwithcross-functionalteamsandfacilitatingteamstoidentifyandimplementsolutionstocomplexproblems14.PriorexperienceworkingwithMicrosoftOfficeproducts15.WorkingknowledgeofGEHCproducts