Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
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 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.
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 BMDAdditional Locations
Work Shift
Success Profile
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Ambitious
- Collaborative
- Goal-oriented
- Persuasive
- Results-driven
- Self-starter