1. JOSE FALCON
Celular: (787) 248-1657
Office: (787) 704-6074
SUMMARY OF QUALIFICATIONS
Extensive experience in the Manufacturing and Quality Assurance areas on Medical Devices and Pharmaceutical
Industries.Excellentinterpersonalskills collaborate with customer teams to identify and remedy quality issues. Well-
versedinall aspectsof productionincludinginventorymanagement,qualityimprovement, safety programs, scheduling
and maintenance. Strongleadershipskills able to train and motivate teams to peak performance. Excellent computer
knowledge; JD Edwards, QIS, LIMS, SAP, Microsoft Office.
Areas of Expertise
 QS RegulationforMedical Devices/ISO 13485.
 Supportingof FDA / ISO13845 (BSI) inspections.
 EvaluationandApproval of Non-conformance documentation.
 Statistical conceptsapplication.
 Evaluationanddispositionof rawmaterial andwork-inprocess.
 Cleanroom-monitoringexperience (RodacRCSParticle count)
 Teamworkorientedandexcellentdecision-maker.
 Experience with SAPsystem.
 Administrate OperatorCertificationSystem.
 Knowledgeof electronicDefectTrackingSystem
 Essential Skillsof ManagingProjects
 Knowledgeof Value StreamMapping&LeanManufacturing
PROFESSIONAL EXPERIENCE
ST. JUDE MEDICAL, LLC, Caguas,PR 5/2005 to present
Senior ManufacturingSupervisor
 Assures daily operation to drive towards short and long terms manufacturing goals
 Monitoring line efficiencies to assure efficient and productive operations
 Monitoring Headcount Management and Line Balancing to comply with Productivity Goals
 Support validations and protocols to facilitate new product launches and assure successful implementation.
 Utilize CAPA and NCMR system to document and answer non-conformance.
 Implement 5s program at sub assembly area.
Key Accomplishments:
 Improved productivityapproximately 15%
 Reduced excess of inventoryfrom 8 daysto 3 days
 Achieve 97% assistanceofsupervisedgroups
 Implementlean projects at MoldProduction & PackagingAreathat improved 15% efficiency.
CARDINAL HEALTH STERILE TECHNOLOGIES, Humacao,PR 9/2004 to 5/2005
SupplyQualityAssurance/ AuditorSupervisor
 Evaluate andimplementthe quality requirements for In-coming materials (receiving/inspection) and contract
services sourced from qualified suppliers including but not limited to periodic supplier cGMPs audits.
 Provide leadership and direction to SQA personnel on customer quality standards management

2.  Verify chemical/packaging components are inspected and released on a timely basis to avoid manufacture
production delays and support on time customer delivery.
 Support product transfer activities and ensure chemical /pkg. Specifications, sampling inspection, and testing
requirements are met.
 Maintainthe ComponentMasterFile (drawingspecifications,labelingdocuments,colorstandardsasapplicable),
and assure specifications comply with customer requirements.
Key Accomplishments:
 Re-establishedsupplierauditsprogram
 Improved ProductRelease by 12%
ManufacturingSupervisor 7/2004 to 9/2004
 Supervise dailyproductionactivitiestoensure compliance with applicablecGMP/ISO/Safety/SOPsrequirements
and that productionscheduleandqualitystandardsare met.
 Maintainand supervise the overall formulation,fillingandpackagingoperationsof assignedproductsandmake
technical decisions.
 Maintainoperations incompliance withestablishedstandardcostandmake revisionsasrequired.
 Identifyimprovementopportunities(costsavings,revenue, andproduction operation) andmake
recommendationtoManagement.
ETHICON, LLC JOHNSON& JOHNSON,San Lorenzo, PR 1989 to 7/2004
ManufacturingSupervisor 3/2001 to 7/2004
 Monitoringefficienciestoassure efficientandproductiveoperations
 Prepare andPerformEvaluationsforsubordinates
 Promoteseffectivecommunicationandteamworktosupportbusinessresults
 Participatesinthe interviewsandselectionof personnel
 Utilize CAPA systemtodocumentandanswernon-conformance.
Quality System Administrator 1997 – March 2001
 In charge of the start-up and manage the Electronic Operator Certification Program (Opcert) plant-wide. Lead
the data loadactivitiestoensure the completion prior to full implementation of the Opcert Electronic system.
Perform software validation and trouble shooting of the electronic system.
Key Accomplishments:
 Implementedprocess certificationsonthe two majorfacilities;EthiconSan Lorenzo,PR and Ethicon SanAngelo,
Texas
 Improved productivityby15%
 ConsistentlyrecognizedforValued Contributions
 Improved certificationmonitoringprocessby80%
 Improved assistanceby8%
EDUCATION
ColumbiaCollege,Caguas,PR
Bachelor Degree in BusinessAdministration