质量体系管理专员工作职责与职位要求
职位描述：
工作职责：
1、负责质量体系相关的制度和流程的制定和发布；
2、协助进行项目管理制度与流程的更新与建立；
3、配合项目监管，制定详细的流程和节点验收标准，负责项目文档管理；
5、协助进行项目日常管理；
6、上级分配的其他任务。
职位要求：
1、生物医学或理工科相关专业本科及以上学历，英语六级以上；
2、3年以上工作经验，1年以上项目管理相关工作经验；
3、工作高效，具备良好的跨部门协调沟通能力及经验；
4、学习能力强，抗压能力强，有强烈的责任心，工作积极主动；
5、具备在生物医药领域工作经验、具有PMP证书优先。
篇2：QMOSpecialist质量体系专员岗位职责描述岗位要求
职位描述：
职责描述：
Summary
?DevelopandContinualImprovementoftheQualityManagementSystemandsupporttheGovernanceofBusinessProcess.
?Ensureexecutionofproperinternalauditstoallcorporatefunctionsformeasuringcompany’scompliancetotheQualitySystemasrequiredbytherelevantISO/VDAStandards.
?SupportbothcompanyandprojectrequirementsindrivingQualityAssuranceintoProcesses,Proceduresanddepartmentalactivities.
DutiesandResponsibilities
(thesearethepositionsessentialdutiesandisnotanall-inclusivelist)
Mainareasofresponsibilitiesare:
?EnsureaproperQualityManagementSystembasedontheGlobaloneisinplaceandcontrolledincompliancewithISO/VDArelevantstandards.
?ParticipateinthedevelopmentoftheQualityManagementSystembasedonBusinessProcessesandtheircontinuousimprovement.
?CoordinatelocalcertificationswithCertificationBodiesandmanageexternalaudits.
?EnsurecompliancetoQualityManagementSystemandrelatedISO/VDAStandardsbyestablishingandperforminginternalauditsthatmeasuretheeffectivenessoftheSystems;includingmanagementoflocalandcross-Countryauditplans.
?EnsurethatQualityManagementSystemdocumentationisupdatedaccordingtoguidelines.
?EnsureeffectiveexecutionoftheProcessesMilestones(QAMM)throughouttheProjectfromKick-offtoClose-out.
?SupportQMOManagerintheimplementationofcommonQualitymethodologies,toolsandinformationsystems,theircontinuousimprovementandalignmentonbestpractices.
?SupportQMOManagerinthemonitoringofQualityKPIs,theanalysisofresultsandthedevelopmentandmonitoringofimprovementplans.
?AssureLessonsLearnedandNonconformityprocessarefacilitatedanddrivenbackintotheBusinessProcessesforcontinuousimprovement.
?ResponsibletoidentifyandcommunicateQualitygeneralconcernsandorissuestoappropriatedepartment.
?Supportcontinuousimprovementactivitiese.g.,Kaizen,5S,SixSigmaprojects,valueengineering,leanmanufacturing,etc.
Knowledge&Skills
?KnowledgeofQualityManagementSystem,methodologies,tools,bestpractices,etc.
?KnowledgeofISO/VDAStandardsprincipleswithinthescopeofapplication.
?ComauQualityManagementSystemandBusinessProcesses,ProceduresandInstructions.
?ISO9001/VDA6.4internalauditorcertification.
?UnderstandingofgeneralCorporateoperationsandbusiness(multipleBUexperienceisaplus).
?Qualityphilosophies–Basicprinciplesandpractices
?ManagementSystemsstandards
?ComauQualityFoundations
?QualityKPI(KeyPerformanceIndicators)
?Quality-specificITtools
?ManagementSystemAuditingSkills
?SupplierAuditingSkills
?GeneralknowledgeofWCMQC-Pillar
?ProblemSolving:Defectanalysisandprevention,
?ReliabilityandRiskManagement
?Customerspecifications(TechnicalandRegulatory)
?OutlineofProductDevelopmentProcess/MilestonesandQualityGatesmanagement
?Chargeback
BehavioralCompetencies
?Teamworkwithcrossfunctionalteams
?Communicationskills,verbal,writtenandfollow-up
?Abilitytointerfaceinamulticulturalenvironment.
?Businessawareness
?Managingrelationships
?Communication
?Personalorganization
?Changeminded&driven
?
Qualifications
?Education:
oBachelordegreeinEngineeringrequiredandorganizationandindustryexperience.
?Previousexperiences
oAminimumof3yearsinQualityAssuranceorProcessQualityManagementexperienceintheautomotiveoralliedindustry.
oExperiencesinEngineering/Manufacturingenvironmentpreferred.
?Languages
oEnglish:fluent
职位要求：
篇3：质量体系专员职位描述与岗位职责任职要求
职位描述：
1.本科学历：药学、生物技术或生物工程等相关专业；
2.两年以上医药/医药包装/医疗器械行业质量体系管理经验，参加过内审和外部审核；
3.熟悉ISO9001、ISO13485、CFDA、GMP质量管理体系，接受过ISO13485或ISO19001的培训，具有内审员资格；
4.熟练使用各种办公软件，如：SAP,Word,Excel,Outlook;
5.能流利的阅读和书写英语；
6.文字表达能力强，能独立建设、编写、汇档体系文件；
7.认真细致，良好的沟通能力和亲和力，责任心强，有团队协作精神，良好的职业操守和敬业精神。
制度专栏
