Analyst I, Complaint Investigation
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Job Description
PositionSummary
The Analyst I, Complaint Investigation specialist is responsible for investigating product complaints, conducting laboratory testing, analyzing technical data, and documenting investigation results to support product quality and regulatory compliance. This role partnerscloselywithmanufacturingsites,suppliers,ProductLegalManufacturer(PLM)teams,QualityEngineers,andothercross-functionalstakeholderstoidentifyrootcauses,resolveproductqualityissues,andensurecompliancewithFDA,ISO,GMP,andGLPrequirements.
The position requires strong attention to detail, effective problem-solving skills, and the ability to work collaboratively in both laboratory and office environments. The Complaint Investigation Specialist I is responsible for conducting and documenting comprehensive complaint investigations, including product testing,andeffectivelyplanning,organizing,andtrackingallactivitiesassociatedwithcomplaintrecords.Astrongcommitmenttoqualityandaccuracyisessentialtoensuretheintegrity,completeness,andregulatorycomplianceofcomplaintinvestigations.
Success in this role is driven by active in-office collaboration, enabling real-time engagement with experienced investigators, laboratory teams,andcross-functionalpartnerstoacceleratelearning,enhanceproblem-solvingcapabilities,andsupporttimelyinvestigationoutcomes.Thisonsitepresencepromotesknowledgesharing,teamalignment,andcontributionstobothindividualanddepartmentalobjectives.
EssentialResponsibilities
- ConductcomplaintinvestigationsforUCCproducts,includingOEM-manufacturedproducts,ensuringtimely,thorough,andcompliantresolution.
- PerformlaboratorytestingandexperimentsinaccordancewithGoodManufacturingPractices(GMP),GoodLaboratoryPractices(GLP),andapplicablequalitysystemrequirements.
- Analyzecomplaintdata,testresults,andtechnicalinformationtoidentifyrootcausesandsupportevidence-basedconclusions.
- Documentinvestigationactivities,testresults,andfindingsaccuratelyandcompletelyinaccordancewithFDA,ISO,andinternalqualitysystemrequirements.
- Manageassignedcomplaintinvestigationrecordsandensuretimelyprogressionandclosureofinvestigations.
- Providetechnicalsupportforproductqualityissues,includingcomplaintevaluation,investigation,andescalationofreportableeventsinaccordancewithregulatoryrequirements.
- Collaboratewithmanufacturingfacilities,suppliers,ProductLegalManufacturer(PLM)teams,andQualitypartnerstosupportinvestigationsandproductqualityimprovements.
- Prepare,operate,maintain,andtroubleshootlaboratoryequipmentandtestinginstrumentsinasafeandcompliantmanner.
- Communicateinvestigationfindings,conclusions,andrecommendationseffectivelytocross-functionalteamsandmanagement.
- Worksafelywithinabiohazardlaboratoryenvironmentwhileadheringtoallsafetypoliciesandprocedures.
- Supportcontinuousimprovementinitiativesandcontributetodepartmentalobjectivesandqualitysystemenhancements.
- Maintainregularonsitepresencetosupportlaboratoryactivities,hands-ontraining,cross-functionalcollaboration,knowledgesharing,andtimelyissueresolution.
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MinimumQualifications
- Bachelor'sdegreeinascientific,lifesciences,engineering,orrelatedtechnicaldisciplinerequired.
- 1-3yearsofexperienceinaregulatedindustry(medicaldevice,pharmaceutical,biotechnology,orsimilar);relevantco-oporinternshipexperiencewillbeconsidered.
- Experienceworkingwithtechnicaldocumentation,laboratorytesting,dataanalysis,andqualitysystemprocesses.
- WorkingknowledgeofFDA,ISO13485,GMP,GLP,andcomplaint-handlingrequirements.
- ProficiencyinMicrosoftExcel,includingfunctionssuchasPivotTables,VLOOKUP/XLOOKUP,andbasicdataanalysistools.
- Strongwrittenandverbalcommunicationskills.
- Demonstratedabilitytomanagemultipleprioritieswhilemaintainingahighdegreeofaccuracyandattentiontodetail.
- ApplicantsmustbeauthorizedtoworkforanyemployerintheUnitedStates.Thecompanyisnotabletosponsorortakeoversponsorshipofanemploymentvisaatthistime.
PreferredQualifications
- Experienceconductingcomplaintinvestigationswithinamedicaldeviceorpharmaceuticalenvironment.
- Laboratorytestingexperience,includingsamplepreparation,testexecution,andequipmentoperation.
- Experiencewithrootcauseanalysismethodologiesandproblem-solvingtools(e.g.,5Whys,Fishbone,CAPA,FMEA).
- Knowledgeofmedicaldevicemanufacturingprocessesandproductqualitysystems.
- ASQcertification(CQE,CQA,CQM,orequivalent)preferred.
Knowledge,Skills,andAbilities
- Workingknowledgeofmedicaldeviceregulationsandstandards,includingFDA,ISO13485,QualitySystemRegulations(QSR),GMP,GLP,andapplicableindustryguidelines.
- Stronglaboratoryandanalyticalskills,includinghands-onexperiencewithtestingmethods,instrumentation,andequipmenttroubleshooting.
- Understandingofmanufacturingprocessesandtheirimpactonproductqualityandcomplaintinvestigationoutcomes.
- Abilitytocollect,interpret,andanalyzetechnicaldataanddrawsound,evidence-basedconclusions.
- Knowledgeofengineeringandscientificprinciplesrelatedtoproductevaluation,failureanalysis,androotcauseinvestigations.
- Effectiveverbalandwrittencommunicationskills,includingtheabilitytopresenttechnicalinformationtocross-functionalaudiences.
- Strongtechnicalwritingskillswiththeabilitytoprepareclear,concise,andwell-organizedinvestigationreportsanddocumentation.
- Excellentorganizationalandtimemanagementskills,withtheabilitytoprioritizecompetingdemandsandmeetdeadlines.
- Abilitytointerpretandapplycorporate,departmental,andregulatoryrequirementswithinaregulatedenvironment.
- Self-motivatedandcapableofworkingindependentlywhilealsocontributingeffectivelywithinateamenvironment.
- Demonstratedcriticalthinkingandsoundjudgmentwhenevaluatingcomplaints,investigationresults,andpotentialregulatoryimpact.
- Abilitytorecognizeandappropriatelyescalateproductqualityconcernsthatmayhaveregulatory,business,orpatientsafetyimplications.
WorkEnvironment
- Primarilyofficeandlaboratory-basedenvironment.
- Requiresroutineworkwithinalaboratorysetting,includingpotentialexposuretobiohazardmaterialswhilefollowingestablishedsafetyprocedures.
- Requiresfrequentuseoflaboratoryequipment,testinginstruments,andcomputersystems.
- Regularonsitepresenceisrequiredtosupportlaboratorytesting,investigatordevelopment,cross-functionalcollaboration,andtimelycomplaintresolution.
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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
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion