監(jiān)督總監(jiān)崗位職責(zé)

上市后監(jiān)督總監(jiān)微創(chuàng)醫(yī)療器械上海微創(chuàng)醫(yī)療器械(集團(tuán))有限公司,微創(chuàng)ThisnewpositionofDirector,PostMarketSurveillance(PMS)isaccountableforoverallstrategy,executionandoversightofallactivitiesassociatedwithcomplainthandlingassociatedqualitymanagementsystems,functionsandregulatorycompliancereportingofAdverseEvents(AEs)andMedicalDeviceReportable(MDRs)throughouttheproductlifecycleforMicroPortCardiovascularbusiness,globally.

?Thiskeyleadershiproleistoensuregovernmentalregulatoryrequirementsaremet,customerexperiencesareappropriatelyloggedandinvestigatedtobothcomplywithlaws/regulations.Thispositionwillfacilitateproactivequalityandassociatedimprovementsincustomerexperience,aswellastoensuretheorganizationisinformedofadversetrendingthroughanalysisofcomplaintsforAdverseEvents,MedicalDeviceReportable,includingtrackingandtrending.

?Directleadershipaccountabilityandoversightofactivitiessuchas(a)uptakeandloggingofcustomercomplaints,(b)theirproperandthoroughinvestigationandsubsequentdocumentation,(c)statisticaltrackingandtrendingandassociatedevaluationandescalationofadversecustomercomplainttrendsandearlyidentificationofnewissues(withpriorityonsafetyissues),(d)properevaluationofsafetyandpatientriskthroughoveralladministrationofaHealthHazardEvaluation(HHE)process,and(e)AEandMDRreporting,andtheassociatedtimeliness.

?AssurescompliancewithregardstoAE/MDRwiththeapplicableinternationalregulatoryrequirements(ie,FDAQSRs,ISO13485,JapaneseMHLW,BrazilianANVISA,EUMDR)forthecompany'sproducts,includingmedicaldevices,andcombinationproducts.Ensuressuccessfulinternalandexternalinspectionsandaudits.

?Ensuretimelinessofallcomplainthandling,adverseevents,andmedicaldevicereportingactivitiesinaccordancetoprocedures,standardsandregulations.

?ResponsibleandaccountableforthecomplianceofallPMSprocessesandprocedures,associateddocumentandperformancemetrics.

監(jiān)督總監(jiān)崗位

篇2:安全總監(jiān)監(jiān)督安全生產(chǎn)責(zé)任制

安全總監(jiān)(監(jiān)督)安全生產(chǎn)責(zé)任制

1.對(duì)輸油公司處長負(fù)責(zé),對(duì)輸油公司安全生產(chǎn)管理工作負(fù)領(lǐng)導(dǎo)責(zé)任;

2.負(fù)責(zé)本單位QHSE管理體系的建立、推廣和實(shí)施工作;

3.組織參加每季度(每月)一次的安全生產(chǎn)檢查和日常生產(chǎn)過程中不定期抽查,并監(jiān)督安全生產(chǎn)檢查情況和隱患的整改;

4.參與工業(yè)生產(chǎn)動(dòng)火方案的審批,進(jìn)行現(xiàn)場(chǎng)監(jiān)督;

5.負(fù)責(zé)組織并參加事故的調(diào)查、分析、處理工作;

6.對(duì)員工三級(jí)安全教育、特殊作業(yè)持證上崗、特種設(shè)備使用情況進(jìn)行安全監(jiān)督;

7.負(fù)責(zé)對(duì)管理處交通車輛、消防管理以及環(huán)境保護(hù)工作進(jìn)行監(jiān)督。安全總監(jiān)(監(jiān)督)安全生產(chǎn)責(zé)任制

1.對(duì)輸油公司處長負(fù)責(zé),對(duì)輸油公司安全生產(chǎn)管理工作負(fù)領(lǐng)導(dǎo)責(zé)任;

2.負(fù)責(zé)本單位QHSE管理體系的建立、推廣和實(shí)施工作;

3.組織參加每季度(每月)一次的安全生產(chǎn)檢查和日常生產(chǎn)過程中不定期抽查,并監(jiān)督安全生產(chǎn)檢查情況和隱患的整改;

4.參與工業(yè)生產(chǎn)動(dòng)火方案的審批,進(jìn)行現(xiàn)場(chǎng)監(jiān)督;

5.負(fù)責(zé)組織并參加事故的調(diào)查、分析、處理工作;

6.對(duì)員工三級(jí)安全教育、特殊作業(yè)持證上崗、特種設(shè)備使用情況進(jìn)行安全監(jiān)督;

7.負(fù)責(zé)對(duì)管理處交通車輛、消防管理以及環(huán)境保護(hù)工作進(jìn)行監(jiān)督。