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一、崗位職責：

1.負責質(zhì)量部管理體系的建立，運行，維護，組織內(nèi)部審核完成內(nèi)審報告及相關(guān)記錄，并監(jiān)督檢查改進和落實情況；
Responsibleforestablishing,operating,andmaintainingthequalitydepartment'smanagementsystem;organizinginternalaudits,completinginternalauditreports,andrelatedrecords;
andsupervisingtheimplementationofcorrectiveactionsandfollow-up.
2.負責組織質(zhì)量工程師對供應商審核及評審設計開發(fā)各階段相關(guān)文件，監(jiān)督設計開發(fā)過程符合性；
Responsiblefororganizingqualityengineerstoconductsupplierauditsandreviewdesignanddevelopmentdocumentsatvariousstages,ensuringcompliancewithdesignand
developmentprocesses.
3.負責醫(yī)療器械產(chǎn)品質(zhì)量管理，依據(jù)質(zhì)量控制程序要求，正確識別各項質(zhì)量管控點，組織制定管理規(guī)程，指導、監(jiān)督執(zhí)行；
Responsibleforqualitymanagementofmedicaldevices,identifyingkeyqualitycontrolpointsbasedonqualitycontrolprocedures,developingmanagementregulations,andguidingand
supervisingtheirimplementation.
4.負責組織專人收集與醫(yī)療器械生產(chǎn)、經(jīng)營相關(guān)的國內(nèi)外法規(guī)標準等有關(guān)規(guī)定、實施動態(tài)管理；
Responsiblefororganizingthecollectionofdomesticandinternationalregulationsandstandardsrelatedtomedicaldeviceproductionanddistribution,andmanagingtheir
implementationdynamically.
5.加強生產(chǎn)過程中的質(zhì)量控制，組織質(zhì)量工程師對質(zhì)量管理中出現(xiàn)的質(zhì)量問題進行分析、判斷和處理，組織實施不合格品處理，執(zhí)行標識、記錄、隔離、臨時措施和/或糾正預防措施、關(guān)閉；
Strengthenqualitycontrolduringproductionprocesses,organizequalityengineerstoanalyze,judge,andhandlequalityissues,implementnonconformingproductmanagement
(includingidentification,record-keeping,isolation,temporarymeasures,andcorrective/preventiveactions),andensureclosureofissues.
6.負責組織對生產(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)范化和標準化，如依據(jù)《醫(yī)療器械監(jiān)督管理條例》、《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)督各部門嚴格執(zhí)行；配合技術(shù)部涉及的驗證工作，組織專人校準相關(guān)設施設備量具及儀表等；
Organizethedevelopmentandreviewofqualitymanagementsystem-relatedprocedures,managementsystems,andSOPstoensurestandardizedandregulatedqualitymanagement.
Thisincludesestablishingacomprehensivequalitymanagementsysteminaccordancewithregulationssuchasthe"RegulationsontheSupervisionandAdministrationofMedical
Devices,""GoodManufacturingPracticesforMedicalDeviceProduction,"ISO13485,andotherrelevantinternationalstandards.Supervisestrictimplementationbyalldepartmentsand
supportvalidationactivitiesrelatedtothetechnicaldepartment,includingcalibrationoffacilities,equipment,gauges,andinstruments.
8.組織質(zhì)量工程師及時收集、分析和處理客戶投訴，組織相關(guān)部門進行原因分析，制定并實施糾正預防措施，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)量目標和質(zhì)量計劃，并將其分解到各個部門和崗位，確保質(zhì)量目標的有效落實和達成；
Basedonthecompany'sdevelopmentstrategyandmarketdemands,formulatequalityobjectivesandplans,breakthemdowntovariousdepartmentsandpositions,andensuretheir
effectiveimplementationandachievement.
10.參與新產(chǎn)品研發(fā)項目的質(zhì)量策劃，從質(zhì)量角度對產(chǎn)品設計、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.負責組織相關(guān)人員實施公司內(nèi)部審核和管理評審；
Responsiblefororganizinginternalauditsandmanagementreviewswithinthecompany.
12.負責迎接外部審核機構(gòu)包括各認證機構(gòu)及客戶的審核和現(xiàn)場檢查工作，如醫(yī)療器械質(zhì)量管理體系的認證審核，積極配合審核工作，及時提供相關(guān)資料和信息，確保企業(yè)順利通過審核和認證;
Responsibleforcoordinatingexternalauditsandon-siteinspectionsbycertificationbodiesandcustomers,suchascertificationauditsofthemedicaldevicequality
managementsystem.Activelycooperatewithauditactivities,providerelevantdocumentationandinformationinatimelymanner,andensurethecompanypassesauditsand
certificationssmoothly.
13.負責部門的日常管理工作，指導、培訓、評估和激勵部門員工，提高部門整體工作效率和氛圍；
Responsibleforthedailymanagementofthedepartment,includingguiding,training,evaluating,andmotivatingdepartmentstafftoimproveoveralldepartmentalefficiencyand
morale.
14.完成上級領導安排的其它工作。
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
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、計量管理知識；
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.具備一定的團隊管理和良好的團隊協(xié)作能力。
Havecertainteammanagementskillsandexcellentteamcooperationabilities.

三、教育背景要求：

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

四、公司基本情況：