Quality Engineer Electrical Engineering
Resume:
Veronica Lacerda
Email: ****************@*******.***
Electrical/Electronic/Quality Engineer
Knowledgeable and experienced Electrical/Electronic/Quality Engineer with over a 20 year record of demonstrating expertise in manufacturing, quality and design of new products and management. Experience includes managing projects and cross functional teams executive reporting and design process.
Key Areas of Expertise
Quality
Audits
Design
Electronic hardware
Validation and Verification
Labview
Test Equipment
Telecommunications
Automation
Programming
Risk and Failure Analysis
Methodologies
Documentation
Reliability
Technical writing
Software
Troubleshoot
Mechanics
IEC 60601
FDA 21 CFR 820
DO-160
IEC 61010
ISO 13485
MIL-STD 810
IEC 62304
ISO 9001
ISO 14971
ISO 9002
MIL-STD 461
MIL-STD 883
AS9100
ISO 14001
Kaizen
Lean Manufacturing
Six Sigma Methodologies
JIT
Professional Experience
Quality Engineer for Bausch and Lomb
Tampa, FL 7/17 – present
Support areas such as aseptic, manufacturing, facilities, design, calibration, utilities and repair.
Work with and approve documents, requalifications, QCR’s, SOP’s, Final Reports, IQ’s, OQ’s, PQ’s and critical work orders.
Responsible for all major changes, designs and issues within production floors.
Trained in aseptic, gowning, SOP’s, FDA guidelines and more and received certifications.
Perform risk assessments and root cause analysis.
Manage shut down activities within the plant, approve work and provide releases.
Maintain high standards of Quality using quality tools and following SOP’s and procedures.
Work with such programs as Kintana, Maximo and Documentum.
Design Test Engineer for Conmed Corp
Largo, FL 7/14 – 4/15, 9/15-12/16
Create system tests for system maturity on several Electro surgical units.
Worked with reliability of products and components.
Created Verification and Validation protocols, procedures and reports and implemented V+V.
Developed test sets for production testing.
Worked with all aspect of design including characterization of components, implementation and maturity of all electronic components for all systems.
Researched and requested product equipment.
Created work instructions
Worked with quality and design for FMEA, risk and root cause
Developed circuitry to simulate boards.
Managed technicians and provided training.
Created drawings test procedures and protocols.
Trained vendor at site on test procedures and troubleshoot on complex PCB’s
Quality Engineer/Quality Assurance for Flextronics
Irving, Tx 6/15 – 9/15
Performed software validation for software tools used for testing and for documentation.
Worked with SQL and C++ for testing and validation.
Worked with root cause analysis and used quality tools
Worked with clinical for performance of intended use, risk analysis and studies
Worked with design development.
Created a system level Verification and Validation protocols plan and report.
Worked with CAPA’s, internal and external audits.
Performed risk assessment for new products.
Developed test plans and protocols for new designs for electroporation.
Manually performed calculations and measurements to verify design requirements.
Sr. Quality Engineer for Bausch + Lomb
Clearwater, FL 2/14 – 7/14
Initiate Non-Conformances for issues related to manufacturing, process, microbiology or complaints.
Investigate Non-Conformances and CAPA’s and perform root cause using statistical data, 5 Y’s, 6 Sigma and/or other quality tools.
Improved processes and procedures of manufacturing.
Worked with such programs as Katana, Documentum, TMSWeb, Catswire, ErPlx, Qlikview, minitab and clearview.
Worked on addressing audit and CAPA issues.
Revised PFMEA’s, updated validations and worked with IQ, OQ and PQ’s.
Quality Engineer for Bovie Medical Corporation
Clearwater, FL 9/12 – 10/13
Developed and conducted Verification and Validation protocols, reports and tests for Usability, Electrical, RF, Software and system testing.
Coordinated the development and documentation of standardized design guidelines, processes, practices and generated system documentation and technical proposals.
Worked with quality tools.
Responsible for assigning corrective action and measuring overall performance.
Worked with CAD drawings related to final assembly and major components within the ICON GS.
Managed from design to production.
Produced DFMEA’s, PFMEA’s, Risk Hazard Analysis, RMP’s, RMR’s and PEMS according to ANSI 60601 second and third editions, ISO 14971, IEC 62304 and FDA standards.
Maintain high standards of Quality by reviewing existing logistics issue data and developing action plans to resolve in a timely manner.
Senior Lead Design Engineer for Global Electronic Testing Services
Odessa, FL 3/12 – 9/12
Manager for designing circuits for components including FPGA’s, BGA’s, PLCC’s and CPLD’s.
Performed tests of electronic components to validate authenticity.
Inspected components for quality using FDA or MIL-STD’s for customer’s use (Medical, Military or Commercial)
Tested components using curve tracer, oscilloscope, power supplies, spectrum analyzer and JTAG.
Designed PCB’s for interfacing with test jigs, JTAG and hardware.
Managed technicians and testing activities.
Technical Writer/Software V+V for Jabil
St Petersburg, FL 11/11 - 1/12
Created test planning, IQ, OQ, PQ protocols, test scenarios, test cases and executed software.
Verification and Validation of software.
Investigated failures and resolved issues related to software.
Manually tested to customer and FDA requirements.
Performed risk analysis.
Manually tested to customer and FDA requirements.
Technical Proposal Writer for CME
Pinellas Park, FL 8/11 – 10/11
Created technical proposals for military companies.
Worked with RFI’s, SOW’s, MIL-STD’s and performance specifications to meet customer design requirements.
Met customer deadlines for proposal presentation.
Related information from potential customers to design engineers for future design standards.
Quality Assurance for Pall Aeropower
New Port Richey, FL 11/10 – 6/11
Created Similarity Analysis Reports, Acceptance Test procedure, Qualification Test Procedures, Quality Test Reports and Certified Test procedures.
Performed Failure Mode Effects Analysis (FMEA), risk analysis and created reports.
Worked with many MIL-Standards such as DO-160, MIL-STD 810, MIL-STD 461 and more.
Compared customer requirements to military standards and ensured equipment was tested and designed to military standards.
Worked with test cases, created test plans, master validation plans and analyzed failures.
Utilized programs such as Enovia, SmarTeam, AS400, Catia V5, Mapics, Framemaker and Microsoft Office.
Instructor for ITT Technical Institute
Pinellas Park, FL 3/10 – 3/11
Trained students in electronic theory such as analog and digital circuits and RF in the associates night program.
Worked with students on the hands on labs and simulations using Multisim.
Quality Assurance/Quality Engineer for Unilens
Largo, FL 1/09 – 11/09
Updated documentation such as master validation plans, safety guidelines for use and other such documents.
Wrote and updated quality processes and procedures, integrated summaries of efficacy and safety for contact lenses.
Worked with documents within the Design History Files.
Created Quality plans, programs, procedures and tools for quality management.
Created flow diagrams, work instructions and evaluated manufacturing processes for efficiency and effectiveness.
Performed root cause and risk analysis using quality tools.
Created Master Validation Plans, analyzed failures.
Performed audits, reviewed past audits and verified for compliance.
Worked with CAPA’s, FMEA’s, NCR’s and clinical trial reports.
Quality Assurance/Quality Engineer/Test Engineer for Baxter Healthcare
Pinellas Park, FL 1/08 – 12/08
Developed Labview programs for automated validation, environmental and stress tests with integrated equipment.
Programmed using Test Stand for several tests.
Created a test set for testing dialysis machines using equipment such as data acquisitions, power supplies, hygrometers, sensors and ESS chamber.
Created circuits to simulate signals needed to work with equipment.
Created prototypes for components within a peritoneal dialysis.
Performed Failure Mode and Effects Analysis (FMEA’s) and created reports
Worked with external and internal audits.
Analyzed root cause of failures for NCR’s and CAPA’s.
Repaired devices to system, software and/or component failure.
Wrote the Acceptance Test Procedure (ATP) and protocols for validation and verification of peritoneal dialysis, Home Choice and Atlas lines.
Created documentation to comprise within the design history file.
Generated and worked with test cases, test plans and manually tested software and hardware.
Used software programs such as DOORS, Clearquest and Mercury.
Manufacturing Engineer/Manager for Zhone
Largo, FL 3/07 – 11/07
Managed teams in manufacturing, technicians, engineers, assemblers and testers.
Kept production and manufacturing going through the night, fixed equipment when needed, assisted in troubleshoot, fixed or created programs and software on equipment when computers restarted.
Worked with the design team on new products
Met production deadlines.
Modified manufacturing process for cost effectiveness and efficiency.
Service Manager for XPEDX
Tampa, FL 1/05 – 3/07
Managed technicians throughout 7 states in the southeast.
Traveled to customer site, custom built or fixed factory equipment.
Worked with Allen Bradley, relays and PCB’s.
Worked with all types of customers including Disney, Havana Cigars and Georgia Foods and corrected issues over the phone, at site or sent a technician to help.
Helped with sales and also sold products while interacting with customers.
Handles irate customers and provided them with great customer service leaving them satisfied and wanting to do more business with the company.
Education / Training
Bachelors of Science Electrical Engineering
Remington College - Tampa, FL
Associates of Science Electrical Engineering
Wentworth Institute of Technology - Boston, Ma
Telecommunications Certification
Wentworth Technical School - Lexington, Ma
HP VEE Training,
Agilent Technologies- Burlington, Ma.
Advanced RF Microwave Training,
Agilent Technologies- Burlington, Ma.
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