一、岗位职责：

1.负责质量部管理体系的建立，运行，维护，组织内部审核完成内审报告及相关记录，并监督检查改进和落实情况；
Responsibleforestablishing,operating,andmaintainingthequalitydepartment'smanagementsystem;organizinginternalaudits,completinginternalauditreports,andrelatedrecords;
andsupervisingtheimplementationofcorrectiveactionsandfollow-up.
2.负责组织质量工程师对供应商审核及评审设计开发各阶段相关文件，监督设计开发过程符合性；
Responsiblefororganizingqualityengineerstoconductsupplierauditsandreviewdesignanddevelopmentdocumentsatvariousstages,ensuringcompliancewithdesignand
developmentprocesses.
3.负责医疗器械产品质量管理，依据质量控制程序要求，正确识别各项质量管控点，组织制定管理规程，指导、监督执行；
Responsibleforqualitymanagementofmedicaldevices,identifyingkeyqualitycontrolpointsbasedonqualitycontrolprocedures,developingmanagementregulations,andguidingand
supervisingtheirimplementation.
4.负责组织专人收集与医疗器械生产、经营相关的国内外法规标准等有关规定、实施动态管理；
Responsiblefororganizingthecollectionofdomesticandinternationalregulationsandstandardsrelatedtomedicaldeviceproductionanddistribution,andmanagingtheir
implementationdynamically.
5.加强生产过程中的质量控制，组织质量工程师对质量管理中出现的质量问题进行分析、判断和处理，组织实施不合格品处理，执行标识、记录、隔离、临时措施和/或纠正预防措施、关闭；
Strengthenqualitycontrolduringproductionprocesses,organizequalityengineerstoanalyze,judge,andhandlequalityissues,implementnonconformingproductmanagement
(includingidentification,record-keeping,isolation,temporarymeasures,andcorrective/preventiveactions),andensureclosureofissues.
6.负责组织对生产批记录的审核及成品放行；
Responsiblefororganizingthereviewofproductionbatchrecordsandreleaseoffinishedproducts.
7.组织编制、审核质量管理体系相关的程序文件、管理制度及SOP等，确保质量管理工作的规范化和标准化，如依据《医疗器械监督管理条例》、《医疗器械生产质量管理规范》、ISO13485及国外相关
体系法规等制定完善的质量管理体系文件，并监督各部门严格执行；配合技术部涉及的验证工作，组织专人校准相关设施设备量具及仪表等；
Organizethedevelopmentandreviewofqualitymanagementsystem-relatedprocedures,managementsystems,andSOPstoensurestandardizedandregulatedqualitymanagement.
Thisincludesestablishingacomprehensivequalitymanagementsysteminaccordancewithregulationssuchasthe"RegulationsontheSupervisionandAdministrationofMedical
Devices,""GoodManufacturingPracticesforMedicalDeviceProduction,"ISO13485,andotherrelevantinternationalstandards.Supervisestrictimplementationbyalldepartmentsand
supportvalidationactivitiesrelatedtothetechnicaldepartment,includingcalibrationoffacilities,equipment,gauges,andinstruments.
8.组织质量工程师及时收集、分析和处理客户投诉，组织相关部门进行原因分析，制定并实施纠正预防措施，防止问题再次发生；
Organizequalityengineerstocollect,analyze,andhandlecustomercomplaints,conductrootcauseanalysiswithrelevantdepartments,andimplementcorrectiveandpreventiveactions
topreventrecurrence.
9.根据公司的发展战略和市场需求，组织制定质量目标和质量计划，并将其分解到各个部门和岗位，确保质量目标的有效落实和达成；
Basedonthecompany'sdevelopmentstrategyandmarketdemands,formulatequalityobjectivesandplans,breakthemdowntovariousdepartmentsandpositions,andensuretheir
effectiveimplementationandachievement.
10.参与新产品研发项目的质量策划，从质量角度对产品设计、工艺选择、原材料采购等环节提出专业意见和建议，确保新产品在研发阶段就符合质量要求；
Participateinthequalityplanningofnewproductdevelopmentprojects,providingprofessionalopinionsandsuggestionsonproductdesign,processselection,andrawmaterial
procurementfromaqualityperspectivetoensurecompliancewithqualityrequirementsduringtheR&Dphase.
11.负责组织相关人员实施公司内部审核和管理评审；
Responsiblefororganizinginternalauditsandmanagementreviewswithinthecompany.
12.负责迎接外部审核机构包括各认证机构及客户的审核和现场检查工作，如医疗器械质量管理体系的认证审核，积极配合审核工作，及时提供相关资料和信息，确保企业顺利通过审核和认证;
Responsibleforcoordinatingexternalauditsandon-siteinspectionsbycertificationbodiesandcustomers,suchascertificationauditsofthemedicaldevicequality
managementsystem.Activelycooperatewithauditactivities,providerelevantdocumentationandinformationinatimelymanner,andensurethecompanypassesauditsand
certificationssmoothly.
13.负责部门的日常管理工作，指导、培训、评估和激励部门员工，提高部门整体工作效率和氛围；
Responsibleforthedailymanagementofthedepartment,includingguiding,training,evaluating,andmotivatingdepartmentstafftoimproveoveralldepartmentalefficiencyand
morale.
14.完成上级领导安排的其它工作。
Completeothertasksassignedbyseniormanagement.

二、任职要求：

1.有8年及以上医疗器械生产企业行业质量管理工作经验
Havemorethan8yearsofworkexperienceinqualitymanagementwithinthemedicaldevicemanufacturingenterpriseindustry.

2.熟悉无菌医疗器械GMP、ISO13485及欧盟MDR、FDA-QMSR等质量管理体系；
FamiliarwithqualitymanagementsystemssuchasGMPforsterilemedicaldevices,ISO13485,EUMDR,andFDA-QMSR.
3.熟悉医疗器械国家法律法规及相关规定、企业质量管理流程、质量体系专业知识、计量管理知识；
Familiarwithnationallaws,regulations,andrelevantprovisionsrelatedtomedicaldevices,aswellascorporatequalitymanagementprocesses,professional
knowledgeofqualitysystems,andmetrologymanagementknowledge.
4.拥有良好的沟通能力，具备分析问题和解决问题的能力；
Possessstrongcommunicationskills,andtheabilitytoanalyzeandsolveproblems.
5.具备一定的团队管理和良好的团队协作能力。
Havecertainteammanagementskillsandexcellentteamcooperationabilities.

三、教育背景要求：

本科及以上学历，医学、药学、生物、医疗器械、机械电子、质量管理等相关专业。蓝帆外科BluesailSurgical
Universitybachelor'sdegreeorabove,withmajorsinmedicine,biology,medical
devices,mechanicalelectronics,qualitymanagement,orrelatedfields.

四、公司基本情况：