About this role
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
PositionSummary
The Senior Quality Systems Engineer - CAPA & Continuous Improvement serves as a subject matter expert (SME) for Quality Systems with primary responsibilityfortheCorrectiveandPreventiveAction(CAPA)process.ThisroleisresponsiblefordrivingCAPAeffectiveness,improvingqualitysystemperformance,andensuringcompliancewithapplicableregulatoryrequirementsandcompanystandards.
The successful candidate will provide technical guidance, coaching, analytics, and continuous improvement support across the organization while partnering with cross-functional teams to ensure quality issues are effectivelyinvestigated,correctiveactionsareimplemented,andqualitysystemprocessescontinuetoimprove.ThispositionalsoservesasakeyresourceforQualitySystemsrequirements,rootcauseanalysis,complianceinitiatives,andqualityperformancereporting.
KeyResponsibilities
CAPALeadership&QualitySystems
ServeastheSubjectMatterExpert(SME)forCAPAprocessesacrosstheorganization.Provideguidanceandcoachingoninvestigations,rootcauseanalysismethodologies,correctiveactions,CAPAdocumentation,andeffectivenessverificationactivities.MonitorCAPAperformanceandensurecorrectiveactionplansarecompletedaccurately,effectively,andontime.Analyzeprocessnonconformancesandsupportthedevelopmentandimplementationofcorrectiveandpreventiveactions.ProvideleadershipandsupportforthetimelycommunicationandescalationofsignificantCAPA-relatedissuestoQualityLeadershipandBusinessUnitleaders.CollaboratewithPostMarketQualitytoensuretimelycompletionofnonconformanceescalationactivitiesandSituationAnalysisreviews.ApplyQualitySystemsprinciplesincludingCAPA,documentcontrol,andrelatedqualityprocessestosupportbusinessobjectives.Provideworkdirection,mentoring,andsupporttoCAPAownersandprojectteamsasneeded. DataAnalytics&Reporting
PerformdataanalysisrelatedtoCAPAandQualityManagementSystem(QMS)performancetoidentifytrends,risks,andimprovementopportunities.Develop,maintain,andpresentqualitymetrics,KPIs,dashboards,andreportsformanagementandseniorleadership.Utilizestatisticaltoolsandmethodologies,includingSixSigma,StatisticalProcessControl(SPC),andDesignofExperiments(DOE),toevaluateprocesseffectivenessandsupportdata-drivendecision-making.SupportCAPAeffectivenessverificationactivitiesthroughstatisticalanalysis,samplingmethodologies,andobjectiveevidence.Delivertimelyandmeaningfulreportstoseniorleadershipregardingqualitysystemperformanceandcompliance. ContinuousImprovement
Championcontinuousimprovementinitiativesthatenhancequalitysystemeffectiveness,compliance,andoperationalperformance.CollaboratewithCAPAstakeholdersacrossmultiplesitestostandardizebestpracticesanddriveglobalprocessimprovements.Influencecross-functionalteamstoadoptconsistentmethodologies,processes,andqualitytoolsacrosstheorganization.Implementimprovementstoqualitysystems,processes,anddocumentationtoincreaseefficiencyandeffectiveness.Supportinnovationandqualityexcellencethroughtheapplicationofdata-drivenproblem-solvingmethodologies. Compliance&QualityPrograms
Supportthedevelopment,maintenance,andcontinuousimprovementofqualityprogramstoensurecompliancewithcompanypolicies,regulatoryrequirements,andindustrystandards.Create,review,revise,andapproveQualitySystemdocumentation.Ensurecompliancewithapprovedqualitymethods,GoodDocumentationPractices(GDP),andqualitysystemprocedures.Assistwithinternalaudits,externalaudits,regulatoryinspections,andresolutionofassociatedfindings.Supportpost-marketsurveillanceactivitiesandquality-relatedprojectsasassigned.RepresenttheQualityorganizationprofessionallyduringinternalandexternalinteractions.Participateinindustryandprofessionalorganizationsasappropriate.Assistwithspecialprojectsandperformotherdutiesasassigned. RequiredQualifications
Bachelor'sdegreeinEngineering,EngineeringTechnology,Science,orarelatedtechnicalfield.Minimumof6yearsofengineering,quality,orqualitysystemsexperience.Strongunderstandingofqualitysystemsregulationsandstandards,including:ISO9001ISO13485FDAQualitySystemRegulations(QSR)EUMDRExperienceworkingwithinregulatedindustriessuchasmedicaldevice,pharmaceutical,biotechnology,orsimilarenvironments.Abilitytoworkeffectivelyinateam-orientedenvironmentanddeliveroncross-functionalobjectives.ExperienceowningormanagingQualitySystemprocesses,particularlyCAPA. PreferredQualifications
Experiencedrivingprocess,product,orqualitysystemimprovements.ExperiencewithTrackWiseorsimilarelectronicQualityManagementSystems(eQMS).ASQCertification(CQE,CSQE,CQA,orrelatedcertification).LeanSixSigmaGreenBeltorBlackBeltcertification. Knowledge&Skills
ExperiencewithelectronicCAPAmanagementsystems(eCAPA).ExperiencemanagingCAPAprocessesinregulatedindustriessuchasmedicaldevices,pharmaceuticals,orbiotechnology.Strongrootcauseanalysisandproblem-solvingskills.AdvancedMicrosoftExcelcapabilities,includingPivotTables,charts,reports,queries,anddataanalysis.Strongappliedstatisticsknowledgeandexperienceusingstatisticaltoolstoimproveprocesscapabilityandsupportqualityinvestigations.UnderstandingofsamplingmethodologiesusedforCAPAeffectivenessverification.Strongunderstandingofauditingprinciplesandqualitycompliancerequirements.Abilitytoanalyzecomplexdataandtranslatefindingsintoactionablerecommendations.Abilitytopresentdataandrecommendationseffectivelytoseniorleadership.ExtensiveknowledgeofQualityManagementSystemsandcross-functionalbusinessrelationships.Excellentcommunication,collaboration,andinfluencingskills.Strongorganizationalandprojectmanagementcapabilities.Abilitytoworkindependentlywhileeffectivelypartneringwithstakeholdersacrossalllevelsoftheorganization. WhatMakesYouSuccessful
Abilitytoleadandinfluencequalityimprovementswithoutdirectauthority.Stronganalyticalmindsetwithapassionforsolvingcomplexqualityissues.Commitmenttocontinuousimprovementandoperationalexcellence.AbilitytocoachandmentorothersonCAPA,investigations,andqualitysystemrequirements.Strongattentiontodetailandcommitmenttocompliance.Collaborativeapproachtoworkingacrossfunctions,sites,andleadershipteams. Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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Primary Work Location
USA GA - Covington BMD
Additional Locations
Work Shift
US BD 1st Shift 8am-430pm (United States of America)