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一、崗位職責(zé)：

1.負(fù)責(zé)質(zhì)量部管理體系的建立，運(yùn)行，維護(hù)，組織內(nèi)部審核完成內(nèi)審報(bào)告及相關(guān)記錄，并監(jiān)督檢查改進(jìn)和落實(shí)情況； Responsibleforestablishing,operating,andmaintainingthequalitydepartment'smanagementsystem;organizinginternalaudits,completinginternalauditreports,andrelatedrecords; andsupervisingtheimplementationofcorrectiveactionsandfollow-up. 2.負(fù)責(zé)組織質(zhì)量工程師對(duì)供應(yīng)商審核及評(píng)審設(shè)計(jì)開發(fā)各階段相關(guān)文件，監(jiān)督設(shè)計(jì)開發(fā)過程符合性； Responsiblefororganizingqualityengineerstoconductsupplierauditsandreviewdesignanddevelopmentdocumentsatvariousstages,ensuringcompliancewithdesignand developmentprocesses. 3.負(fù)責(zé)醫(yī)療器械產(chǎn)品質(zhì)量管理，依據(jù)質(zhì)量控制程序要求，正確識(shí)別各項(xiàng)質(zhì)量管控點(diǎn)，組織制定管理規(guī)程，指導(dǎo)、監(jiān)督執(zhí)行； Responsibleforqualitymanagementofmedicaldevices,identifyingkeyqualitycontrolpointsbasedonqualitycontrolprocedures,developingmanagementregulations,andguidingand supervisingtheirimplementation. 4.負(fù)責(zé)組織專人收集與醫(yī)療器械生產(chǎn)、經(jīng)營相關(guān)的國內(nèi)外法規(guī)標(biāo)準(zhǔn)等有關(guān)規(guī)定、實(shí)施動(dòng)態(tài)管理； Responsiblefororganizingthecollectionofdomesticandinternationalregulationsandstandardsrelatedtomedicaldeviceproductionanddistribution,andmanagingtheir implementationdynamically. 5.加強(qiáng)生產(chǎn)過程中的質(zhì)量控制，組織質(zhì)量工程師對(duì)質(zhì)量管理中出現(xiàn)的質(zhì)量問題進(jìn)行分析、判斷和處理，組織實(shí)施不合格品處理，執(zhí)行標(biāo)識(shí)、記錄、隔離、臨時(shí)措施和/或糾正預(yù)防措施、關(guān)閉； Strengthenqualitycontrolduringproductionprocesses,organizequalityengineerstoanalyze,judge,andhandlequalityissues,implementnonconformingproductmanagement (includingidentification,record-keeping,isolation,temporarymeasures,andcorrective/preventiveactions),andensureclosureofissues. 6.負(fù)責(zé)組織對(duì)生產(chǎn)批記錄的審核及成品放行； Responsiblefororganizingthereviewofproductionbatchrecordsandreleaseoffinishedproducts. 7.組織編制、審核質(zhì)量管理體系相關(guān)的程序文件、管理制度及SOP等，確保質(zhì)量管理工作的規(guī)范化和標(biāo)準(zhǔn)化，如依據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》、《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》、ISO13485及國外相關(guān) 體系法規(guī)等制定完善的質(zhì)量管理體系文件，并監(jiān)督各部門嚴(yán)格執(zhí)行；配合技術(shù)部涉及的驗(yàn)證工作，組織專人校準(zhǔn)相關(guān)設(shè)施設(shè)備量具及儀表等； Organizethedevelopmentandreviewofqualitymanagementsystem-relatedprocedures,managementsystems,andSOPstoensurestandardizedandregulatedqualitymanagement. Thisincludesestablishingacomprehensivequalitymanagementsysteminaccordancewithregulationssuchasthe"RegulationsontheSupervisionandAdministrationofMedical Devices,""GoodManufacturingPracticesforMedicalDeviceProduction,"ISO13485,andotherrelevantinternationalstandards.Supervisestrictimplementationbyalldepartmentsand supportvalidationactivitiesrelatedtothetechnicaldepartment,includingcalibrationoffacilities,equipment,gauges,andinstruments. 8.組織質(zhì)量工程師及時(shí)收集、分析和處理客戶投訴，組織相關(guān)部門進(jìn)行原因分析，制定并實(shí)施糾正預(yù)防措施，防止問題再次發(fā)生； Organizequalityengineerstocollect,analyze,andhandlecustomercomplaints,conductrootcauseanalysiswithrelevantdepartments,andimplementcorrectiveandpreventiveactions topreventrecurrence. 9.根據(jù)公司的發(fā)展戰(zhàn)略和市場需求，組織制定質(zhì)量目標(biāo)和質(zhì)量計(jì)劃，并將其分解到各個(gè)部門和崗位，確保質(zhì)量目標(biāo)的有效落實(shí)和達(dá)成； Basedonthecompany'sdevelopmentstrategyandmarketdemands,formulatequalityobjectivesandplans,breakthemdowntovariousdepartmentsandpositions,andensuretheir effectiveimplementationandachievement. 10.參與新產(chǎn)品研發(fā)項(xiàng)目的質(zhì)量策劃，從質(zhì)量角度對(duì)產(chǎn)品設(shè)計(jì)、工藝選擇、原材料采購等環(huán)節(jié)提出專業(yè)意見和建議，確保新產(chǎn)品在研發(fā)階段就符合質(zhì)量要求； Participateinthequalityplanningofnewproductdevelopmentprojects,providingprofessionalopinionsandsuggestionsonproductdesign,processselection,andrawmaterial procurementfromaqualityperspectivetoensurecompliancewithqualityrequirementsduringtheR&Dphase. 11.負(fù)責(zé)組織相關(guān)人員實(shí)施公司內(nèi)部審核和管理評(píng)審； Responsiblefororganizinginternalauditsandmanagementreviewswithinthecompany. 12.負(fù)責(zé)迎接外部審核機(jī)構(gòu)包括各認(rèn)證機(jī)構(gòu)及客戶的審核和現(xiàn)場檢查工作，如醫(yī)療器械質(zhì)量管理體系的認(rèn)證審核，積極配合審核工作，及時(shí)提供相關(guān)資料和信息，確保企業(yè)順利通過審核和認(rèn)證; Responsibleforcoordinatingexternalauditsandon-siteinspectionsbycertificationbodiesandcustomers,suchascertificationauditsofthemedicaldevicequality managementsystem.Activelycooperatewithauditactivities,providerelevantdocumentationandinformationinatimelymanner,andensurethecompanypassesauditsand certificationssmoothly. 13.負(fù)責(zé)部門的日常管理工作，指導(dǎo)、培訓(xùn)、評(píng)估和激勵(lì)部門員工，提高部門整體工作效率和氛圍； Responsibleforthedailymanagementofthedepartment,includingguiding,training,evaluating,andmotivatingdepartmentstafftoimproveoveralldepartmentalefficiencyand morale. 14.完成上級(jí)領(lǐng)導(dǎo)安排的其它工作。 Completeothertasksassignedbyseniormanagement.

二、任職要求：

1.有8年及以上醫(yī)療器械生產(chǎn)企業(yè)行業(yè)質(zhì)量管理工作經(jīng)驗(yàn) Havemorethan8yearsofworkexperienceinqualitymanagementwithinthemedicaldevicemanufacturingenterpriseindustry.

2.熟悉無菌醫(yī)療器械GMP、ISO13485及歐盟MDR、FDA-QMSR等質(zhì)量管理體系； FamiliarwithqualitymanagementsystemssuchasGMPforsterilemedicaldevices,ISO13485,EUMDR,andFDA-QMSR. 3.熟悉醫(yī)療器械國家法律法規(guī)及相關(guān)規(guī)定、企業(yè)質(zhì)量管理流程、質(zhì)量體系專業(yè)知識(shí)、計(jì)量管理知識(shí)； Familiarwithnationallaws,regulations,andrelevantprovisionsrelatedtomedicaldevices,aswellascorporatequalitymanagementprocesses,professional knowledgeofqualitysystems,andmetrologymanagementknowledge. 4.擁有良好的溝通能力，具備分析問題和解決問題的能力； Possessstrongcommunicationskills,andtheabilitytoanalyzeandsolveproblems. 5.具備一定的團(tuán)隊(duì)管理和良好的團(tuán)隊(duì)協(xié)作能力。 Havecertainteammanagementskillsandexcellentteamcooperationabilities.

三、教育背景要求：

本科及以上學(xué)歷，醫(yī)學(xué)、藥學(xué)、生物、醫(yī)療器械、機(jī)械電子、質(zhì)量管理等相關(guān)專業(yè)。藍(lán)帆外科BluesailSurgical Universitybachelor'sdegreeorabove,withmajorsinmedicine,biology,medical devices,mechanicalelectronics,qualitymanagement,orrelatedfields.

四、公司基本情況：