1. Amanda J Bush
6885 Chaparral Lane,Newcastle, CA 95658
614-783-6048
ajbush1959@gmail.com
Objective
To secure a positionwithinastable andprofitableorganizationthatprovidesachallengingenvironmentand
makesuse of my experience inleading/managing cross-functionalteamsinavarietyof productdevelopment
activities.
Summary of Qualifications
 Thirtyfive yearsexperiencedeveloping,implementingandmanagingcomplex consumer,medically
regulated,andgovernmentprojectswithintime andbudgetaryconstraints
 Applicationof QSR,MDD, ISO9002, 13458, 14971, IEC62304, 60601, 62366 as these standardsrelate
to medical devices(hardware andsoftware)
 Organized,detail-oriented,datadriven,andconscientiousself-starter,abletostrategize andprioritize
effectivelytoaccomplishmultipletasksandremaincalmunderpressure
 Skilledlistenerandcommunicator,able toassessclientneedsandconveynecessaryinformationwith
clarityand enthusiasm
 Excelsat workingwithcross-functionalrepresentativestoestablishthe businessenvironmentculture
throughdirectauthorityandorganizational influence.
 Computerskillsinclude:MSOffice Suite, MSProject,OmniPlan,MSVisio,OmniGraffle,AgileMD
(ProductLifecycle Management),SmartBearALMComplete,Lucidchart,Smartsheet
SynGen, Inc.
Date of Employment: June 2015 - Present
SynGen,Inc.
Sacramento,CA
Design Quality Engineer
 Responsibilities includesupport,maintenanceandprocessimprovementswithrespectto
SynGen’s QualityManagementsystem.
 Responsible forreviewingandapprovingInstallation,Operational,ProcessandPerformance
Qualifications,formanufacturingprocessatSynGen’scontractmanufacturing.
 Reviewandapprove Device HistoryandMasterRecordsforClassI and II products,as well as
general laboratoryequipment.
 Responsible formanagingqualityprocessesassociatedwithsupplierselection,includingbutnot
limitedto:initialassessments,yearlyaudits, assigningSCARs,andworkingwithcontract
manufacturerstodispositionandresolve findings,supplierbusinessreviewsinsupportof
managementreview,generatingandmonitoringdeviationsinsupportof manufacturingof SynGen
products.
 Responsible forSynGen’sinternal auditprogram, includingscheduling,performingdesignhistory
file audits,andsupplieraudits.Responsible fortrainingnew internal auditors,andproviding
mentoringand oversight.

2. Amanda J Bush
2
WANDA, Inc.
Date of Employment:October2014 – June 2015
WANDA, Inc.
San Francisco,CA
Program Manager
 Responsibilities included,performingconfigurationmanagement,developingandimplementing
Quality ManagementsystemforClinical DecisionSupportsoftware.
 Responsible forwritingandperformingInstallation,Operational,ProcessandPerformance
Qualifications,withrespecttodeployingsoftware device tocloud. CreatedandmaintainedDevice
Historyand Master Recordsforsoftware device.
 Responsible forimplementationof CHFmonitoringprogramatWANDA customerfacilitiesthat
included settingupinteractivevoice response (IVR) system, WANDA system, andpatient
interventionprocess,cliniciantraining,onboardingof patientstoIVRandWANDA system,and
monitoringpatientadherence toCHFmonitoringprogram.
 Responsible forcustomersupportoperationsincludingfeedback,complaints,andsystem training.
 Responsible forregulatoryaffairsactivitiesincludingpreparationof technical filegenerationin
supportof CE mark activitiesforsale of productinEU, and postmarketsurveillance of device.
 Performeddesignverificationandvalidationtesting,includingplanningandexecutionof EndUser
Validationtesting.
fda360, LLC
Date of Employment:March2014 – September2014
fda360, LLC
Loomis,CA
Principal
 Responsibilities included,performingconfigurationmanagement,material handlingandtracking
for large projects,developingQuality,ConfigurationManagement,Document/DataManagement,
and Material Control plans. Performed ManufacturingCoordinatorduties,whichincluded
interactingwithvendors,manufacturers,and clientstaff tocoordinate the buildof engineering
prototypes,designverificationtestunits,andclinical devices (ClassII/III).
 Lead the preparationof 510(k) submissions,writingandperformingInstallation,Operational,
Processand Performance Qualifications. CreatedandmaintainedDevice HistoryandMaster
Recordsfor clients’device.
 Participatedonclient’sdevelopmentteamasa QualityEngineer,foraClassII medical device,
responsible fornonconformingmaterial processincludingidentifying,resolvingandreporting.
Participatedinclient’sFailure,Modes,andEffectsAnalysisonnew hardware beingdevelopedfor
the same ClassII device.

3. Amanda J Bush
3
Intel-GE Care Innovations, LLC
Date of Employment: August2012 – February2014
Care Innovations
Roseville,CA
Program Manager
 Responsible forcumulativelytrackingtime,costandscope of projectsthatimpactthe near-term
deliverydatesforthese projects.
 Responsible tothe Product DevelopmentManagerforstrategyaspectsthat considerthe
multidimensional impacts,thataffectsthe overallhealthandeffectivenessof the programoverthe
longterm.
 Responsible formanaging consumerproduct sustainingprioritiesandcommitmentsduring market
betaengagements
 Facilitatedmorningengineeringstandups;refined&maturedrequirements,made sure thatthe test
matrix & traceabilitywere correctgiventhe increaseinbrowsercoverage for medical device.
 Responsible forreviewing bothBATandtestregressioncoverage for consumerandmedical devices
withthe testteams,510(k) impactassessmentswithRA,labelsandlabelingplansforQuickStart guides
and videoswiththe UIteamand she updatedourrisk matrices.
 Maintainingdevelopmentteamfocus onseveral veryhardproblemsidentifiedashighrisksearlyonin
the projectplan.Those riskswere realizedandraised atthe rightlevel of concernandvisibilitywith
managementthroughweeklyprogramupdatesand Software ExecutionTeamand Management
Review Committeemeetingswithexecutives.
 Responsible forinformingthe decision makerstoextendthe productdevelopmentwindowandkept
everyone informedasto the level of complexityandriskinvolvedinthe design.Once the decisionwas
made to adjustthe design, drove teamestimatesforprototyping,development,characterizationand
testto reflectthe shiftin programmilestones forproductrelease.
 Responsible forreportingprogram/projectmetrics toprovide amore detailedassessmentof program
status,testcase coverage (applets,browsers&functions),defectassessmentsandcoverage across
platformcomponents.
 Drive cross-functionalteams toclosure/release formedical device asProgramManager.Balance
appropriate responsibilitiesandControl PlanexpectationswithSystemsEngineering.
 Manage the Control Planaspects,as theyrelatedcrossfunctionally, of the BAA dedicatedinstance
‘bringup’for product. Thisincludedoversightforthe final ProcessQualification,BasicAcceptance Test
and approvals.
 Drive ProgramManagementalignmentwithSystemsEngineering,SWEngineering,UserExperience,
Regulatory,SalesandMarketing,Business Operations andTesttooptimize intendedfeatures&
deliverablesfromthe ProductBacklogfor new productdevelopment includingoptimizingsub-releases
to delivermembervalue tomarketfaster

4. Amanda J Bush
4
Intel-GE Care Innovations, LLC
Intel Corporation
Date of Employment: June 2008 – August2012
Care Innovations - Roseville,CA
Intel Digital Health–Folsom, CA
Director Quality Management System, Management Representative
 Responsible forestablishingandmaintainingthe processesneededforQualityManagementSystem
(QMS) to ensure compliance withISO13485: 2003 and21 CFRPart 820 Medical Device Quality
SystemRegulations.
 As the managementrepresentativereportedonthe performance of the QMSto managementwith
executiveresponsibilitythroughmanagementreviewsandensuredrelatedcorrective/preventive
actionswere carriedout.
 Promotedawarenessandaccountabilityforthe applicationof the QMS forproductstargeted for
consumerfinishedgoods,personal healthandhealthcare informationtechnologymarkets.
 Lead a cross-functionalteaminsupportof successful ISO13485 and 14971 audits.
 Lead a cross-functionteaminsupportof FDA inspections resultinginNAI andFDB(CaliforniaFood
and Drug Board) inspections.
 Lead a teamof documentcontrol specialistsandQMSprocessstakeholdersin re-writingQMSto
supportjointventure betweenIntel andGEHealthcare.
Battelle Memorial Institute
Date of Employment: June 1979 – May 2008
Battelle Memorial Institute
ColumbusOhio
Project Manager – Medical Device Solutions
 Mid-levelprojectmanagerresponsibleforleadingprojectteamactivitieswithinanISO13485
certifiedqualitymanagementsystem, associatedwiththe designanddevelopmentof medical
devices (ClassII/III).Responsibilitiesincludedusingprojectmanagementmethodologiesand
toolsto track budgetsupto and including$5Mand schedulesfromafew weeksto2 years.
 In thisrole,provedcapabilitytocomplete assignmentswithoutestablishedproceduresand
performedawide varietyof complex tasksandresponsibilities.Performedprojectmanagement
dutiesforsetupof accuracy test lab. Led projectteaminvalidationof teststations including
software andtestequipment,reviewedvalidationprotocolsfortechnical relevancy,andlab
setupforfunctionalityandefficiency. Providedclientwithweeklystatusreportsincludingcost
tracking,schedulingandissue resolution. PerformedQualityControlfunction byreviewing
validationdatatoensure accuracy,good documentationpractices, andrelevancyto
requirements. Trainedprojectteamonclientspecificstandardoperatingprocedures. Worked
withPDSQualitySystemManagerto addressclientauditobservations.

5. Amanda J Bush
5
Quality System Specialist – Environmental, Safety, Health and Quality
 ServedonBattelle’sQualityOperationCommittee,toassistotherqualitystaff withissues,
procedure development,audits,andauditfinding/observation resolution. WorkedwithESH&Q
VISION teamtoperformgap analysiswithinproductlinestodeterminegapsinquality. Made
recommendationstoeachof the productline managersforprocessimprovementsrelatedto
theirindividual businesses,whichincluded methoddevelopment,informationtechnology
assessment,andproductdevelopment.
 Reviewedproposalsforrisksrelatedtotesting,product/workperformedtoathirdparty
standard,deliverableswhichmustbe certifiedbyathirdparty,and classifiedproposalsthat
were drivenbyrequirementsdefinedinStatementof Work.
Project Specialist – Product Development Solutions
 Responsibilities included,performingconfigurationmanagement,material handlingandtracking
for large projects,developingQuality, ConfigurationManagement,Document/Data
Management,andMaterial Control plans. Performed ManufacturingCoordinatorduties,which
includedinteractingwithvendors,manufacturers,clients,andBattelle staff tocoordinate the
buildof engineeringprototypes,designverificationtestunits,andclinical devices (ClassII/III).
 Workedwitha customerto organize andwrite validationreportspriortoan FDA audit,file
management,andISO-registeredQualitySystemProcedures.
 Coordinated projectactivitiesincludingtravel,time schedules,taskperiodof performance,and
monthlyreports. Interfaced withclientsconcerningschedulingactivitiesformanufacturing
transition.
 Participated inthe preparationof IND/PMA/NDE/510(k) submissions,writingandperforming
Installation,Operational,ProcessandPerformance Qualifications. Createdandmaintained
Device HistoryandMaster Recordsfor clients’ devices.
Technician
 In thisrole,supported CancerResearchFacility,Aerosol,andEnvironmental Sciences,studies.

6. Amanda J Bush
6
Professional Education
ISOConfigurationManagement
GMP 101
GMP Beyondthe Basics
Verification/Validation(CheckpointConference).
Stat-a-Matrix ProcessMapping
Stat-a-Matrix Value StreamMapping
Stat-a-Matrix Facilitation
ASQVoice of the Customer
ASQWebinar:Root Cause AnalysisGettingStarted
ASQWebinar:Root Cause Analysis—TheTools
ASQWebinar:Keysto ImprovingQualityPerformance throughEmployee Ideas
QPC 7 ManagementTools
SuperiorProjectManagement (ThomasLearning,Inc.)
Professional Certification
PMP – (525306, ingood standing, expires5/2018)
CQA – (65029, expires12/2019)
Academic Education
Datesof Attendance : September2005 – December2007
Otterbein Westerville,Ohio
GPA: 3.735
Major of study:BusinessAdministrationwithQualityProcessEmphasis
 Dean’sListDecember2007
References
Referencesare available uponrequest