Asst. Quality Manager助理品质经理

AssistantQualityengineeringmanagerisresponsibleforoverseeingthequalityofproducts,andprocesses,andverificationandvalidationactivitiesduringNewProductDevelopment.Interfaceswithcustomers,Supplier,andvariouscross-functionaldepartments,Sales,ApplicationEngineering/Engineering,ProjectManagerstoensurethecompany’sproductsmeetorexceedcustomerexpectationsintermsofQualityaswellasqualificationtimeline.DUTIESANDRESPONSIBILITIES• EstablishQualityControlPlanstoensureproductandprocessqualityduringNewProductDevelopmentmeetcustomerspecificationrequirements.Planandmonitorprocessvalidationactivitiestoensureprocesscapabilityverifiedandvalidated.MonitorrequiredNPDdeliverablesofeachphasesarewellmaintained.• ReviewingproductdesignspecificationstogetherwithEngineeringtoensurethattheymeetindustrystandardsforsafetyandperformance.• Asprocessowner,workwithcrossfunctionalteamtoensureallnecessaryqualityactivities(APQP)arerigorouslyaddressedduringinitialproductreleaseandchangesuchas:processmapping,processFMEA,qualitycontrolplan,Processcharacterization,Processvalidation(IQ,OQ,PQ),GR&R/MSA,linereleaseandramp-upmonitoring.• Ensuresthatestablishedmanufacturinginspection,samplingandstatisticalprocesscontrolproceduresarefollowed.AssurecompliancetointernalandexternalspecificationandstandardssuchasGMPandISOregulation.Evaluatesandanalyzestheeffortsinorganizing,documenting,andinterpretinginspectionsupportdocumentsandrecords.• Manageproductreleasebyensuringfinalacceptanceinspectionandtestsonfinishedproductsontimefollowingestablishedprocedure.ReviewDeviceHistoryRecordstoensurecompleteness.Performshipmentauthorizationtoensurethatproductsfordistributionareapprovedforrelease.• SupportplantwideCOS(Lean)efforttodrivecontinuousimprovementonqualitybusinessprocessviapokeyokemethodologyandcreateaneffectiveandefficientworkenvironmentandreducetotalcostofquality.• ReviewandapproveECO,Deviation,andvalidationreports.• SetqualityobjectivesandKPIsandreviewandassesson-goingperformanceofdirectreports.Planning,scheduling,andconductingtrainingsessionsforemployeesonbestpracticesinqualitycontrolmethodsandtechniques.LEADERSHIP&TEAMMANAGEMENT• Workcollaboratively,negotiateandengagewithkeystakeholderstofacilitatedeliveryandcompliancewithQualityrequirements.• Developandmaintainstrongrelationshipswithinternalandexternalstakeholderstoensureoptimalperformance.Managingconflictandchanges.• Proactivelycontributetocreatingagoodteamatmosphere.Takeownershipofteamcohesion.• Goodpersonalleadership(EmotionalIntelligence,Authenticity,LearningandAdaptive).• Build-to-qualityinsteadofinspect-to-qualitymindset.REQUIREMENTS&QUALIFICATIONS• Bachelororabovedegreeinmechanicalengineeringorelectricalengineeringrelated.• FluentinEnglish/Chinesewritingandspeakingisamust.Excellentpresentationskillrequired.• 5yearsoraboveofexperienceinmedicaldeviceindustryand/orcableassemblyindustryproductquality,qualityengineeringandNewProductDevelopmentQuality.2yearsofmanagementexperience.• Excellentknowledgeofqualityproblemsolvingmethods,sixsigmablackbeltisaplus.• Detailoriented,abilitytoeffectivelyhandlemultiplepriorities,flexibilitytoreorganizeandrescheduleworkonshortnoticetomeettightdeadlines,haveastrongqualitymindsetandenjoyworkinginateamenvironment.
• GreatanalyticalskillandSPCdriven.