Eric J. Garrett, Senior Quality Engineer

197 Lake Drive “A” Atlanta, Georgia 30340 Phone 317-771-7375 Email: ericg5343@gmail.com

Personal Profile: 18+ years of experience in the Medical Device (Clinical and Manufacturing), and Automotive industry Well versed in ISO 9000, ISO 13485, ISO 16464, FDA CFR 820, TS-16949, APQP and PPAP Proficient in the Product Development Process and DHF creation and maintenance Experienced in plastics, polymers, molding, metals machining, sonic welding, cleanrooms, electronic circuit

boards (PCB’s), SMT and many other technologies. Very effective at problem identification, root cause analysis and corrective action processes. 5 Why’s, Fishbone,

Kaizen, 4ME.

Education: Burris Laboratory School, Elementary, Ball State University, Enhanced Curriculum, PhD led gifted instruction, 1-6 Muncie Central High School – Muncie Indiana – College Prep and Industrial Technology Focus – 1990 US Army Signal Corp – Fort Gordon, Georgia – Communications / Electronic Repair Technician – 1991 Ivy Technical College - Muncie, Indiana - Emergency Medical Technician, Top Graduate, (EMT) – 1992 US Army Academy of Health Science – Fort Sam Houston, Texas - X-Ray Technician, 98% Proficiency Award – 1993 Ball State University – Muncie, Indiana – Bachelor of Science, Industrial Engineering Technology – 1998 American Society for Quality – Chicago, Illinois – ISO 13485 Implementation and Auditing – 2005 Greenbelt Certificate – King Systems – Noblesville, Indiana – Lean Manufacturing Work Cells / Scrap and Waste

Reduction totaled $282,000.00 - 2009 BSI TS - 16949 Auditing Certification – Auburn, Alabama – Certificate – 2014

Engent Electronics / Aerotek Contract Engineering, Norcross, Georgia – October 2015 – April 2016 / Contract Senior Quality Engineer – Automotive and Medical Device – 6-month contract

While at Engent I was responsible for installing and PPAP'ing a robotic manufacturing assembly line for electronic LED headlights which produced 2,000 sets a week, 12,000 headlamps. I worked closely with the Program Manager and contacts in Monterrey, Mexico on any quality issues or concerns. I also managed supplier quality for their suppliers out of Germany and China. During this 6 month contract the line performed very well once error proofed, (Poke-Yoke) and I consistently ran a DPPM or PPM of less than 1,000. Ran a 99.99997% FTPR once I had all the processes validated. I accomplished error proofing, validation and PPAP completion - Level 5, 17-Step within 3 months. While at Engent I also trained associates on GMP, work instructions, SMT, IPC 610 and J-Standard, managed CAPA's and non-conformances, collected and reported performance data for my lines and the SMT electronic manufacturing processes. Completed contract successfully.

Alcon Contact Lenses / Astrix Engineering, Johns Creek, Georgia – May 2015 – October 2015 / Contract Senior Quality Engineer – Medical Device – 6-month contract.

While at Alcon I was responsible for the periodic review of IQ, OQ, PQ validation for 33 contact lens manufacturing lines. Each year Alcon reviews their documentation, validations, non-conformances, CAPA's, IQ, OQ and PQ's for all machinery and processes. I was an integral part of this effort working to bring every requirement into compliance with FDA CFR-820 and ISO 13485. Contract ended due to lack of assignments at the time.

Sanmina, SCI / All States Contract Engineering, Huntsville, Alabama - February 2014 – December 2014 / Contract Senior Quality Engineer – Medical Device – 6-month contract, extended. Focus was on customer launches and quality improvement of those lines. Customers included Philips Ultrasound, Northern Digital, Bosch and Stryker.

Daily tasks involved working on quality problems for those customers, managing NCMR’s, CAPA’s, Supplier Corrective Actions and tracking line performance to achieve a minimum 95% first time pass rate.

Responsibility included installing/launching a new clean room for the manufacture of Bluetooth capable drug monitoring devices. Accomplished task under budget and prior to goal date.

Wrote all clean room procedures per ISO 14644 requirements, helped set up clean room activities with team and conducted training. Clean room validation was achieved by conducting IQ, OQ and PQ on equipment and processes.

Achieved clean room Class 7 (10,000) certification. Completed contract successfully.

Kimball Electronics, Jasper, Indiana - March 2013 – August 2013 / Senior Quality Engineer – Medical Device Ensured timely and responsive management of Kimball’s second largest customer, Philips Medical International.

Closed corrective actions, developed FMEA’s and Control Plans, managed Calibration, held Kaizen Root Cause Analysis events, managed RMA Failure Analysis as well as projects tied to Continuous Improvement.

Responsible for multiple Philips devices including life support systems, breathing devices such as CPAP machines and respiration monitoring sensors.

Quick to respond to all quality issues and proactively improve the manufacturing processes by collecting data on the various failure modes and reducing the defect rates. Resigned to care for terminal parent.

Tridien Medical, Fishers, Indiana - March 2011 – January 2013 / Senior Quality Engineer – Medical Device Responsible for start-up manufacture of medical beds for Stryker and Hill Rom. Implemented ISO 13485 at new site and helped plant achieve certification in September 2012. Responsible for the open and closure of corrective actions, FMEA development, Control Plans, Calibration, Validations (IQ,

OQ, PQ) for equipment and processes and Document Control. Performed and participated in internal, customer and ISO 13485 audits. Reported Quality department metrics on a monthly basis to executive management. Managed 2 Quality Inspectors. Position ended due to company financial issues, laid off.

Advantage Technical Resourcing, Lebanon, Indiana - October 2010 – February 2011 / Contract Quality Engineer – 6-month contract.

Daily tasks involved working on quality problems for Tier 1 suppliers and review of new part submission's (FA’s) and the initiation and closure of corrective actions. Cleared a two year CAPA backlog by end of contract.

King Systems Corporation, Noblesville, Indiana - March 2009 – May 2010 / Supplier Quality Engineer – Medical Device Responsible for the quality of medical devices – Validated products and processes for molded and extruded laryngeal

airways, anesthesia ventilation filters, optical laryngoscopes and King anesthesia masks. Successfully launched airway production in China in 4 months on site. Position ended after sale to Consort and then Ambu.

Darnell US Army Medical Center, Fort Hood, Texas - July 2005 – November 2008 / X-Ray Technician Deployment, responsible for obtaining radiographic images of patients in a timely manner. Worked with patients primarily in the burn unit. I was honored with the DAMC Achievement Coin for proficiency of tasks by expanding on current techniques to increase

patient comfort and radiographic quality. Honorable Discharge with Recognition for Outstanding Duty.

United Technologies - Carrier, Indianapolis, Indiana - May 2003 – January 2005 / Quality Engineer Responsible for the quality system and plan for two new HVAC lines, International Comfort Products, which produced 2,000

furnaces per day. Used SPC – Control Charting, UCL-LCL, Capability Studies, QCPC – Quality Checks, Process Checks and various other quality

tools such as Process Certification, Ishikawa Fishbone, 5 Why analysis, Kaizen, 4M’s and IQ, OQ, PQ validation to drive part and process improvement.

Certified all lines I was responsible for CPK and quality goals. Developed gaging and control charting for critical processes. Saved money by reducing scrap on a monthly goal basis. Total saved during career at UT – $32,000.00. Workforce

reduction and eventual move to Mexico.

Guide - General Motors, Anderson, Indiana - July 1998 – February 2003 / Manufacturing Engineer III Provided expert 4 color tail light molding and tooling technical assistance – managed quality issues, problems with molds,

made specialized assembly equipment parameter adjustments. Performed extensive validation work on processes and machines. Experienced with machine pneumatics, hydraulics, use of

Fanuc Robots, and process control equipment. Managed Preventative Maintenance and upgrade projects saving GM a total of 1.6 million dollars by identifying through

vibration analysis and temperature data - problems before they caused failure and downtime. Plant relocated to Mexico.