Medical Devices Production Manager

Ada Brito

*** **** ** ** **: * Hialeah FL *****

786-***-****. (ad5c4k@r.postjobfree.com)

Manufacturing Industry Management, Manufacturing Process, Quality, Training

Professional 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 FDA–regulated manufacturing operations Class III and Class VIII medical devices, with extensive understanding of GMP, and GDP methodologies.

Areas of Competence

oLeadership/Owner Ship

oSupervisory/Management

oCommunication Skills

oNew Product Development & Introduction

oProduct Transfer

oEquipment’s/Calibration

oProblem Solving

oGap Analysis

oRoot Cause Analysis

oFailure Modes & Effects Analysis

oProcess Validation (IQs, OQs, PQs)

oProcess improvement (Lean MFG, revalidations)

oTraining

oDocument Control

oCAPA & CAR Management

oMOC FDA Audit Backroom

oFDA Audit Backroom

Nov/2022 to Present

EastEndMedical

Cardiovascular Medical Device Manufacturer Industry Miramar FL

Production Manager/ Supervisor

Responsible for the coordination, facilitation and supervision of all activities in the MFG areas

Oversee and coach 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. 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 WKI’s are followed at all times.

Responsible to supervise that traceability and accuracy controls are followed when building product

Ensure 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 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' expectations.

Perform periodic audits to the MFG process and procedure for improvement

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 regarding 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's Degree (Major: Organizational Management)

2003: Compumed School of Miami. (Nursing Assistant/Phlebotomy Tech.)

1996: George Washington High School of New York. (GED Diploma)

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Professionals References:

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