確保企業(yè)質(zhì)量管理體系有效運(yùn)行,保障產(chǎn)品全生命周期符合法規(guī)、標(biāo)準(zhǔn)及客戶要求,通過持續(xù)改進(jìn)提升
產(chǎn)品質(zhì)量和企業(yè)合規(guī)能力,最終實(shí)現(xiàn)對(duì)患者安全的保障和市場競爭力的增強(qiáng)。
Toensuretheeffectiveoperationoftheenterprise'squalitymanagementsystem,guarantee
thattheentireproductlifecyclecomplieswithregulations,standards,andcustomer
requirements.Improveproductqualityandtheenterprise'scompliancecapabilitiesthrough
continuousimprovement,andultimatelyachievetheprotectionofpatientsafetyandthe
enhancementofmarketcompetitiveness.
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:
單雙休(早8點(diǎn),晚5點(diǎn)),法定節(jié)假日全放;
入職繳納五險(xiǎn)一金,有餐補(bǔ),三節(jié)福利,在職體檢,定期聚餐等,工作氛圍好,公司環(huán)境好,領(lǐng)導(dǎo)和藹可親,公司發(fā)展穩(wěn)定。