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PHONE NUMBER AVAILABLE (EMAIL AVAILABLE)Manufacturing Industry Management, Manufacturing Process, Quality, TrainingProfessional experience in the Manufacturing of Medical Devices, Injection Molding, and Calibration Industries. Skilled in Manufacturing/Quality Staff Supervisory Employing a sense of Leadership while utilizing a fair and consistent management approach in leading and developing teams to meet business objectives. Innovative Training Professional with excellent ability to deliver training programs. Knowledge in FDAregulated manufacturing operations Class III and Class VIII medical devices, with extensive understanding of GMP, and GDP methodologies.Areas of CompetenceoLeadership/Owner ShipoSupervisory/ManagementoCommunication SkillsoNew Product Development & IntroductionoProduct TransferoEquipments/CalibrationoProblem SolvingoGap AnalysisoRoot Cause AnalysisoFailure Modes & Effects AnalysisoProcess Validation (IQs, OQs, PQs)oProcess improvement (Lean MFG, revalidations)oTrainingoDocument ControloCAPA & CAR ManagementoMOC FDA Audit BackroomoFDA Audit BackroomNov/2022 to PresentEastEndMedicalCardiovascular Medical Device Manufacturer Industry Miramar FLProduction Manager/ SupervisorResponsible for the coordination, facilitation and supervision of all activities in the MFG areasOversee and coach MFG employees.Responsible for the completion of employees performance reviews and compensationResponsible for managing disciplinary issues, as well as maintaining and promoting a high level of integrity, and employee morale.Responsible for ensuring compliance with quality system regulations. keep the MFG employee's training record in compliance. GDP are followed.Enforce strict safety guidelines and company standards (Code of conduct/Ethics/etc...)Responsible for communicating top management expectations and goals to employees.Guarantee along with the MFG Team that the product is built with high quality and WKIs are followed at all times.Responsible to supervise that traceability and accuracy controls are followed when building productEnsure the safe and correct use of equipment and tools. Verification of calibration stickers and maintenance are up to date.Responsible for tracking productivity, efficiency, yield, and scraps, identifying issues, and providing feedback to the engineering team for improvement.Create, update, review, and approve documentation.Be on the lookout for opportunities to improve the procedures and processes using Lean Manufacturing methodsProvide the necessary support to MFG Engineers and Quality Engineers to run EOs for testing. (Validation and revalidation of processes, components, vendors)Review and approve repair orders, Costumers complaints, NC Investigations, CARs and CAPAsSep/2021 to Nov/2022National MoldingPlastic Injection Molding Miami Lake FLProduction Manager/ SupervisorOrganize workflow by assigning responsibilities and preparing schedules for a 3rd shift teamOversee and coach employees of 3rd shift.Set daily/weekly/monthly objectives and communicate them to employeesIn charge of employee training and (Implemented training program/Metrix for Process Techs, Inspectors, and Material handlers)Ensure the safe use of the molding press and verify that regular maintenance has been completedCheck production output according to specifications/ Track parts reject and material reject KPIIdentify issues in efficiency and suggest improvementsProvide the necessary support to MFG Engineers and Quality Engineers to meet customers' expectations.Perform periodic audits to the MFG process and procedure for improvementReview process procedures and update according to processesJun/2017 to July/2021Johnson &Johnson (Codman)Medical Device Manufacturer Industry Miramar FLProduction Supervisor IIUnderstand customer needs and requirements to provide products with high efficiency and qualitySet daily/weekly/monthly objectives and communicate them to employeesOrganize workflow by assigning responsibilities and preparing schedulesOversee and coach employeesEnsure the safe use of equipment and schedule regular maintenanceCheck production output according to specificationsSubmit reports on performance and progressIdentify issues in efficiency and suggest improvementsTrain new employees on how to safely use machinery and follow procedures (GMP/SOPS/WIP)Enforce strict safety guidelines and company standards (Code of conduct/Ethics/etc.)Be on the lookout for opportunities for improvement of the procedures and processesKeep accurate documentation and perform statistical analysisProvide the necessary support to MFG Engineers, Quality Engineers, and the Training department in any task related to the production floor.Proficient in SAPApr/2013-Jun/2017 Bolton MedicalMedical Device Manufacturer Industry Sunrise FLTechnician, Quality IVerification of equipment calibration labels are updatedPerform product/label validation testing and log results, and qualify or validate equipmentsPerform failure investigations, root cause analysis, and write reports.Generate, conduct, and close NCR investigations timely and to a high level of qualityGenerate engineering changes for procedures and process improvement, provide justifications for changesPrevious experience with QSR and medical device field standards regulationsTrained to different inspection methods in order to provide support to the quality inspection team, if necessaryDec /2011- Apr/2013 MDI Calibration, Inc.Calibration Laboratory Miami FLTechnician Quality IIPerform Investigation for customers complaints and nonconformance; Determine root cause of failures and perform the corrective actionPerform training to the quality manual and ISOs, document and keep records of training updatedPerform internal audits of the quality system documentation to be in compliance with the ISOsAssisting quality manager on the changes of quality, technical documentation, and records to be in compliance with ISOsPerforming monthly audits of the calibration system and calibration standards, sending tools out to vendors for calibrationHosting customers, accreditation/re-accreditation audits to the quality system and technical side.Updating paperwork and printing calibration cert. for customersSupporting the office and customer service areasTrained and certified in the receiving and shipping processSept/2010- Sept/2011 Boston Scientific Corporation PHONE NUMBER AVAILABLEMedical Device Manufacturer Industry Miami FLTechnician, Quality IREASON FOR LEAVING: The company moved to Costa RicaVerification of equipment calibration labels are updatedPerform product/label validation testing and log results, and qualify or validate equipmentsPerform failure investigations, determine root cause of failures and write reportsGenerate and conduct NCE investigations timely and to a high level of qualityGenerate engineering changes on procedures and processes, and provide justifications for changesAssist in preparing and presenting external complaint presentation every month. Perform station audits and supportmanufacturing lines in any aspect related to quality mattersTrained and certified to new revisions of manufacturing procedures, quality control standards, GMP, company-Previous experience with QSR and medical device field standards regulationsAug/2002- Aug/2010 Boston Scientific Corporation PHONE NUMBER AVAILABLEMedical Device Manufacturer Industry Miami FL(Trainer/Team Leader/Mat Handle Back Up)Provide Support to the manufacturing supervisorTrain operators to specific manufacturing procedures and quality inspections of productDocument quality issues (NCE) and ensure that all documents regarding work are filled accurately and completelyPerform transactions in PDM and SAPFacilitate the staffing of the area to optimize workflow/output. Perform line Clearance and ensure all tools are calibrated/currentSupport Continuous Improvement Initiative. Perform transactions in PDM and SAP (Creating WO, issuing/confirming Materials. Maintain proper storage of all materials.Ensure material requests are delivered in a timely fashion. Monitor inventory levels and set line locationsMay/1999-Jul/2001 Cordis Johnson & Johnson Miami FLMedical Device Manufacturer IndustryTrainerREASON FOR LEAVING: The company moved to MexicoContinuously sought ways to further my knowledge/understandingTrained other operators to procedures and proper use of equipmentResponsible for producing quality workEducation: 2011: Graduated from Polytechnic Univ. of Miami. Bachelor's Degree (Major: Organizational Management)2003: Compumed School of Miami. (Nursing Assistant/Phlebotomy Tech.)1996: George Washington High School of New York. (GED Diploma).Professionals References:These should be provided upon request |
