Medical Device Customer Service
Resume:
Ada Brito
*** **** ** ** **: * Hialeah FL *****
786-***-****. E-Mail (adzmpo@r.postjobfree.com)
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Professional Overview
Professional experience in the Manufacturing of Medical Devices, Injection Molding, and Calibration Industries. Skilled in Quality, Manufacturing, and Training, as well as troubleshooting production processes. Innovative Training Professional with excellent ability to deliver training programs for production personnel. Knowledge in FDA–regulated manufacturing operations Class III, and Class VIII medical devices, with extensive understanding of GMP, and GDP methodologies.
Objective
To obtain a position where I can utilize my experience, expand my knowledge, and contribute to the organization's success.
Nov/2022 to Present
EastEndMedical
Cardiovascular Medical Device Manufacturer Industry Miramar FL
Production Manager/ Supervisor
Oversee and coach 13 to 17 MFG employees.
Responsible for the completion of employee’s performance reviews and compensation
Responsible 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. keeping the MFG employee's training record in compliance. Including New Hires training, and OJT training. And producing high-quality products as well.
Enforce strict safety guidelines and company standards (Code of conduct/Ethics/etc...)
Ensure the safe use of equipment, and verify calibration stickers and maintenance are up to date.
Responsible for communicating top management expectations and goals to employees.
Responsible for tracking productivity, efficiency, yield, and scraps, to Identify issues and provide 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 methods
Provide 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, CAR’s and CAPA’s
Sep/2021 to Nov/2022
National Molding
Plastic Injection Molding Miami Lake FL
Production Manager/ Supervisor
Organize workflow by assigning responsibilities and preparing schedules for a 3rd shift team
Oversee and coach employees of 3rd shift
Set daily/weekly/monthly objectives and communicate them to employees
In 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 completed
Check production output according to specifications/ Track parts reject and material reject KPI
Identify issues in efficiency and suggest improvements
Provide the necessary support to MFG Engineers and Quality Engineers to meet customers expectation.
Perform audit to the MFG department and host external audits from vendors/certification
Review process procedures and update according to processes
Jun/2017 to July/2021
Johnson &Johnson (Codman)
Medical Device Manufacturer Industry Miramar FL
Production Supervisor II
Understand customer needs and requirements to provide products with high efficiency and quality
Set daily/weekly/monthly objectives and communicate them to employees
Organize workflow by assigning responsibilities and preparing schedules
Oversee and coach employees
Ensure the safe use of equipment and schedule regular maintenance
Check production output according to specifications
Submit reports on performance and progress
Identify issues in efficiency and suggest improvements
Train new employees on how to safely use machinery and follow procedures (GMP/SOP’S/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 processes
Keep accurate documentation and perform statistical analysis
Provide the necessary support to MFG Engineers, Quality Engineers, and the Training department in any task related to the production floor.
Proficient in SAP
Apr/2013-Jun/2017 Bolton Medical
Medical Device Manufacturer Industry Sunrise FL
Technician, Quality I
Verification of equipment calibration labels are updated
Perform product/label validation testing and log results, and qualify or validate equipment’s
Perform failure investigations, root cause analysis, and write reports.
Generate, conduct, and close NCR investigations timely and to a high level of quality
Generate engineering changes for procedures and process improvement, provide justifications for changes
Previous experience with QSR and medical device field standards regulations
Trained to different inspection methods in order to provide support to the quality inspection team, if necessary
Dec /2011- Apr/2013 MDI Calibration, Inc.
Calibration Laboratory Miami FL
Technician Quality II
Perform Investigation for customers’ complaints and nonconformance; Determine root cause of failures and perform the corrective action
Perform training to the quality manual and ISO’s, document and keep records of training updated
Perform internal audits of the quality system documentation to be in compliance with the ISO’s
Assisting quality manager on the changes of quality, technical documentation, and records to be in compliance with ISO’s
Performing monthly audits of the calibration system and calibration standards, sending tools out to vendors for calibration
Hosting customers, accreditation/re-accreditation audits to the quality system and technical side.
Updating paperwork and printing calibration cert. for customers
Supporting the office and customer service areas
Trained and certified in the receiving and shipping process
Sept/2010- Sept/2011 Boston Scientific Corporation 305-***-****
Medical Device Manufacturer Industry Miami FL
Technician, Quality I
REASON FOR LEAVING: The company moved to Costa Rica
Verification of equipment calibration labels are updated
Perform product/label validation testing and log results, and qualify or validate equipment’s
Perform failure investigations, determine root cause of failures and write reports
Generate and conduct NCE investigations timely and to a high level of quality
Generate engineering changes on procedures and processes, and provide justifications for changes
Assist in preparing and presenting external complaint presentation every month. Perform station audits and support
manufacturing lines in any aspect related to quality matters
Trained and certified to new revisions of manufacturing procedures, quality control standards, GMP, company-
Previous experience with QSR and medical device field standards regulations
Aug/2002- Aug/2010 Boston Scientific Corporation 305-***-****
Medical Device Manufacturer Industry Miami FL
(Trainer/Team Leader/Mat Handle back Up)
Provide Support to the manufacturing supervisor
Train operators to specific manufacturing procedures and quality inspections of product
Document quality issues (NCE) and ensure that all documents regard to work are filled accurately and completely
Perform transactions in PDM and SAP
Facilitate the staffing of the area to optimize workflow/output. Perform line Clearance and ensure all tools are calibrated/current
Support 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 locations
May/1999-Jul/2001 Cordis Johnson & Johnson Miami FL
Medical Device Manufacturer Industry
Trainer
REASON FOR LEAVING: The company moved to Mexico
Continuously sought ways to further my knowledge/understanding
Trained other operators to procedures and proper use of equipment
Responsible for producing quality work
Education: 2011: Graduated from Polytechnic Univ. of Miami. Bachelor Degree (Major: Organizational Management)
2003: Compumed School of Miami. (Nursing Assistant/Phlebotomy Tech.)
1996: George Washington High School of New York. (GED Diploma)
Skills: Proficient In the use of Windows 2007, Word, Excel, Outlook, Access, SAP,
ERP, QuickBooks, Lean Manufacturing,
Bilingual English/Spanish.
Professionals References:
Carlos Cruz Quality Director at EastEndMed
Eddy Segura Senior Manufacturing Engineer at EastEndMed
Angel Herrera Quality Engineer/Manager at Bolton Medical
(305) 717 821
Erickson Rivera Plant Manager at National Molding
Jorge Dias Manufacturing Supervisor at Boston Scientific
(786)385- 4032
Aaron Davis Quality Manager at Boston Scientific
(954)591- 6643
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