Quality Assurance Engineer

EXPERIENCE HIGHLIGHTs

Guldmann Inc.

Technical Support Technical Support to all service technicians and

**/**** - */**** ********** as well as Training of the Hospital

Personnel in the use and repair of the equipment.

Participated in all quality assurance activities

as assigned.

Create and process all necessary documentation to

comply with FDA Regulations. 21 CFR part 11.

Visit to different sites for repairs, maintenance

and Quality Control.

Worked under the Quality Assurance Manager to

develop and maintain all Customer Data and

information for equipment tracking as service

history and incident reports for failures in the

field.

Worked with the Corrective Team regarding defect

follow ups and participated in the root cause

analysis and solution implementation.

Responsible for updating and maintaining the

Quality Data for all the defects found during

regular field operation.

Managed multiple projects.

Baxter Performed validation testing of Hemo and

Tampa, FL Peritoneal Dialysis making sure compliance with

Validation Engineer cGMP.

07/2005 - 08/2007 Develop and maintain record keeping for

experiments performed and perform troubleshooting

and calibration of instruments.

Design, prepare, execute, and analyze

Installation Qualifications (IQs), Operational

Qualifications (OQs), Performance Qualifications

(PQs), and Process Validations (PVs) to approve

equipment, processes, and software used in

medical devices.

Performing calibration, and qualification of

Occlusion Blood Pump and ancillaries.

Utilized pH meters, temperature meter, and a

voltmeters to perform calibration of the

different subsystems.

.

Lead Tech Validation Gather past Design History Files, Compile and

index the test cases. Matching requirements to

existing test reports, Identify gaps in testing

and create tests to cover the gaps and finally

complete the Device History Records (DHF).

Work with a cross functional team to complete

experiments, analyze data and determine Gaps and

require testing.

Review of the tracking databases (Clear-Quest)

analyzing each outstanding product issue for

adequate solution and disposition.

Review of all Engineering Changing Orders (ECOs)

and CAPAs to make sure they comply with the

Regulatory Affairs Department.

Create Technical Files for the Arena and System

1000 Devices.

Responsible of maintain calibration and service

records for the testing units.

Factory Authorized Verification/Validation of the repair procedures

Medical Scope and processes.

Deerfield Beach, FL Train the personnel on the different procedures.

Q/A Technician

01/2002- 08/2005 Final quality inspection of equipment and

documentation prior to shipment.

Althin Medical Develop and adapt procedures, techniques, tools,

Miami Lakes, FL materials and equipments to meet special needs in

Validation Technician order to perform validation protocols.

04/1997 - 10/2001 Writing experimental reports, summaries and

protocols.

Develop and maintain record keeping for

experiments performed and perform troubleshooting

and calibration of instruments.

Commissioning of new installation performing

calibration and protocols to test the units were

performing according to specifications.

Manufacturing Engineering Responsible for providing engineering support to

sustain and improve existing manufacturing

Technician processes.

Transfer and validate new products and processes

into manufacturing operations.

Identify opportunities to increase product

quality and reduce manufacturing costs.

Coulter Electronics Develop and adapt procedures, techniques, tools,

Miami, FL materials and equipments to meet special needs in

Validation Technician order to perform validation protocols in a

08/1995 - 04/1997 Hematology Unit.

Calibration of the Hematology unit using real

human blood and compare the results with those of

the reference unit.

Dover Elevator Service all the different aspects of the

Santo Domingo, RD elevator. Electrical Motors and DC controllers.

Service Engineer Commissioning of the equipment and final

1985 - 07/1995 adjustments that included some parameter and time

changes in the PLC controller.

Education Bachelor In Science Electrical Engineering

Universidad Catolica, 1980

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