Software Design Quality Assurance EngineerStraight from Thermo Fisher Scientific’s careers page. Apply on the company site — no recruiter, no middleman.
PythonJavaC++SQLAPIDockerKubernetesAWSAzureGCPGitLinuxWindowsAgileScrumCI/CDDevOpsMachine LearningAIDeep LearningComputer VisionNatural Language ProcessingData ScienceData EngineeringBig DataSparkHadoopKafkaSQL ServerPostgreSQLMongoDBCassandraRedisElasticsearchOracleMySQLSpringDjangoFlaskNode.jsReactAngularVue.jsHTMLCSSJavaScriptTypeScriptBashShellPowerShellAnsibleChefPuppetTerraformCloudFormationJenkinsGitLab CICircleCITravis CIDocker ComposeDocker SwarmKubernetesOpenShiftAmazon EKSAmazon ECSAzure Kubernetes ServiceGoogle Kubernetes EngineIstioPrometheusGrafanaELK StackSplunkDatadogNew RelicDynatraceJiraConfluenceTrelloAsanaSlackMicrosoft TeamsZoomGoogle MeetWebexSalesforceSAPOracle ERPWorkdayTableauPower BIQlik SenseLookerMicroStrategySSISInformaticaTalendAWS GlueAWS Data PipelineAWS EMRAWS RedshiftAWS RDSAWS DynamoDBAzure Data FactoryAzure DatabricksAzure Synapse AnalyticsAzure SQL DatabaseAzure Cosmos DBGoogle Cloud DataflowGoogle Cloud DataprocGoogle Cloud BigQueryGoogle Cloud SQLGoogle Cloud SpannerGoogle Cloud FirestoreSnowflakeDatabricksAmazon S3Amazon GlacierAmazon EBSAmazon EFSAzure Blob StorageAzure FilesAzure Disk StorageGoogle Cloud StorageGoogle Cloud FilestoreGoogle Cloud Persistent DiskRESTGraphQLgRPCSOAPJSONXMLYAMLProtobufSwaggerOpenAPIISO 13485IEC 6230421 CFR 820ISO 14971QMSSDLCDHFCAPAIVDRUONPIFDAEUcybersecurityAIrisk managementchange controltrainingprocess improvementproject managementsoftware developmentquality assurancequality controltestingvalidationverificationdocumentationcomplianceregulatory affairsauditsinspectionsrisk analysishazard analysismedical devicesoftware as a medical devicelife sciencespharmaceuticalclinical diagnosticsgeneticsgenomicsproteomicscell biologyprecision medicinedrug discoveryhuman identificationforensicsCAR-T cell therapycomputer-aided designprecision engineeringadditive manufacturingcloud engineeringinstrument developmentassay developmentsoftware systemsproduct developmentinfectious diseasesinherited diseasesreal-world impactcareer goalslife sciences solutionsdesign qualitycompliancesoftware product developmentregulatory guidanceglobal cybersecurity standardsQMSsoftware product developmentsoftware engineeringsystemsproduct teamsdesign-compliant company proceduressoftware engineering procedurestraining modulesIVD-oriented cultureDesign Quality for Software as a Medical Deviceproject leadershipsoftware design qualityprogramsbusiness impactregulatory impactdesign quality expertisenext generation NPIsoftware systemsinstrument systemscoachleadenable software teamsdeliver products efficientlycompliance with FDA and EU regulatory standardsprocess improvementcontinuous process improvement initiativessoftware product developmentcybersecurityAI adoptionrisk managementpre- and post-market supportchange controlevolving training curriculumenable and promote cultural adoptiondesign compliant SDLC activitiesstudy evolving global standardsperform gap assessmentsincorporate process improvement opportunitiesproject executionprovide guidanceSDLC activitiesenable design complianceinternal proceduresregulatory/international standardscollaborate with project leadersensure effective DHF managementcomplex regulated product developmentfacilitate SDLC process activitiesprovide consultationcomplaint handlingchange managementCAPA process activitieslead risk managementsoftware hazard analysis activitiesproject/program levelserve as Software Design Quality SMEregulatory compliance auditsinspectionsminimum qualificationsBS in computer scienceengineeringbiologysimilar technical subject areadirect experience in software product development activitiesproduct concept to launch5-10 years of experienceFDA/EU regulated environmentsISO 13485understanding of design control activitiesplanningdesigndevelopmentverificationvalidation of Software as a Medical DeviceIEC 62304working knowledge of ISO 1497121 CFR Part 11project planningadvanced computer skillsprofessional characteristicsability to organize and manage your time and activitiesmultiple, concurrent projectswork attitudedrivecreativitycollaborationdecision makingambitionability to build and maintain relationshipsproject team membersall subject areassoftware engineeringregulatoryprogram managementhighly functioning Design Quality SMEdynamicmulti-disciplinary business and scientific environmentleadership skillsproven track record influencing othersleading significant changeexcellent interpersonalverbalwritten communication skillsEnglish
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