质量工程师（有源产品线）工作职责与职位要求
职位描述：
主要职责：
1、负责有源医疗器械开发过程中的性能验证、测试和过程确认
2、负责撰写有源医疗器械的质量文件和记录
3、确保有源医疗器械的开发过程满足法规的要求
4、有源产品研发质量体系的维护和优化
5、公司安排的其他任务
职位要求：
1、本科以上学历，机械电子、通信工程等相关专业
2、具有5年以上有源产品的开发或质量控制经验，有体系考核和迎审经验
3、了解ISO13485质量体系及有源医疗器械相关产品标准（如GB9706，IEC60601，GB14710等）
4、较强的独立工作能力和良好的团队合作
篇2：质量工程师（新品研发质量）工作职责与职位要求
职位描述：
职责描述：
1.机电专业大专以上
2.3年以上机电行业产品研发或质量管理经验
3.熟练使用各种办公软件
4.熟悉质量管理体系，熟悉常用的质量管理方法
5.掌握质量控制和数据分析方法，有一定的写作能力
6.具备良好的沟通协调能力及较强的工作责任心
7.向制造部和技术部有关责任人索取新产品的各项资料
8.根据资料拟定新产品质量要求
9.制定试制产品质量评审的检验标准
10.编写产品质量先期策划工作总结报告
11.对已投产新产品的质量进行跟踪调查，分析产品存在的质量问题
职位要求：
篇3：质量工程师（供应商质量管理）工作职责与职位要求
职位描述：
ObjectivesofthePosition
?ByleadingthecrossfunctionalteamwithinBSCandsuppliers,thisincumbentshouldbuildtheprocessthroughwhichtheoptimumsupplybaseisdefined,developed,managedandmeasuredtosupporttheneedsofbusiness.
?Actasfocalcontactforsupplierqualitymanagementsystemanddrivetheimprovementofsupplierperformance.
?MaintainandimproveQualitySystemforCJsite
MainTasks
?Workwithinternalstakeholderstosetthetargetandreviewsupplyassurance,measuresupplierdeliveryperformanceandserviceleveltoBSCperiodically.
?Supportidentifiedsupplierstoachievebetteralignmentbetweentheircompany’splansandactivitiesandBSC’sprioritiesandobjectives.
?Documentandputintousesupplierqualityrequirements;assessqualityperformanceandmanufacturingprocessofsignificantsuppliers.
?Setdifferentiatedperformancetargetswithallsuppliersanddocumentedevidenceofresults.Outcome/progressisformallycommunicatedtosuppliers.
?Workwithotherfunctionsasvirtualteamtoconducttheregularqualityandcraterauditintheareaofthesupplierofrawmaterials,operatingsuppliesandequipmentwithfocusonabsenceofsilicone.
?Regularperformanceassessmentstakeplaceforkeysuppliersinordertodrivecontinuousimprovementinrelationtothecurrentandfutureneedsofthebusiness.
?DealwithNCMissues,formalizetheNCMhandlingprocesswithinternalstakeholders;coordinatethecommunicationprocessbetweenQCandsupplierifthereisargumentoccurreduntilcaseclosing.
?ManagealldocumentationrelatedtosupplierincludingbutnotlimitedtoEHSauditreport,siteassessmentreport,qualityauditreport,NCMhandlingreport,deliveryperformancereport,etc.
?Identify,evaluate,improvequalitysystembasedonIATF16949.Ensurethecontinuingsuitability,adequacyandeffectivenessoftheQMS
?Identifythegapsofqualitymanagementsystemforcontinuousimprovementbasedoncomplaint,KPI,InternalNC,etc.
MinimumEducationandQualificationRequiredforthePosition
?Education:UniversitydegreeinChemicals.ProfessionalCertificationwouldbeaplus.
?WorkingExperience:＞3yearsworkingexperienceinsupplierqualitymanagement;multinationalcompanyworkingexperienceispreferred
?Technical&ProfessionalKnowledge:
Handsonexperienceonsupplieridentification,qualificationandassessment;experienceinsupplierimprovementormutualdevelopment
Excellentcommunicationandinterpersonalskill
FluentlanguageskillbothinspokenandwrittenEnglish
Abilityofworkingwithcross-functionalteam
Knowledgeofqualitytools(APQP,PPAP,MSA,SPC,FMEA)
KnowledgeofIATF16949auditabilityishighlypreferred
制度专栏
