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Quality Management Engineering Expert Witness

Provides Opinion & Testimony In:

Quality Management, FDA Compliance certification of medical device manufacturing, Quality systems development, Gap Analysis, Standards Compliance, ISO QS Desk Quality Audits, Process control, Quality Manual, FDA 820 compliance, ISO 9000, ISO 2000 ISO 13485 registration

Expert Witness No.1957

Indiana

Education

Bachelor Of Electronic Engineering/Minor Industrial Engineering, University Of Dayton                             

Corporate Training

GE- Black Belt
GE- Black Belt Train The Trainer
MRP I & II-Material Planning
Supervisory Training
Team Building

Project Management  – Pert

6 Sigma-Black Belt

Black Belt-Train the Trainer
ISO/9000 Overview

Work History

2001-present Medtronics Lead Quality Auditor – Providing technical support to suppliers relative to their conformance to all ISO/ FDA & corporate requirements to quality systems, Functions include performing ISO and FDA compliance audits, developing and implementing audit procedures, interfacing with all suppliers relative to quality system requirements and assisting in supplier development. Responsible for performing Gap analysis of supplier Quality Systems to FDA 820, ISO9000 & ISO13485 requirements

1999-2000 Midwest Stamping  – Senior Quality Engineer – Assist in coordinating the total quality control program and procedures, ensure functional and dimensional verification of metal stamped parts. Responsible for APQP, PPAP, supporting all quality function including FEMA, SPC, control plans, flow charts and capability studies. Administer sub-suppliers and track their progress. Initiate in-process inspection procedure and exercise 8-D problem solving techniques. Administer disposition of defective parts and tracked rejected material. 

1983-1999 General Electric/Lockheed Martin – Electronic Controls Division
Equipment Engineer- Provided hands on day-to-day support activities for the manufacturing of controls. In this capacity performed a variety of tasks such as floor support the manufacturing processes, of solder and assembly of electronic controls. Activities included business support functions, training, plant layout, facilities rearrangements and proposal support. Assisted in documentation to obtain ISO9000 certification.
Operations Manager- Responsible for the day-to-day supervision of 150 union hourly production employees in the manufacturing of electronic controls.  Also, had responsible for meeting cost, quality and delivery commitments.  Developed team building concepts and began implementing lean
manufacturing, empowerment, problem solving and decision making abilities of the workforce.      
           
Senior Manufacturing EngineerDeveloped and implemented plans to meet all customer requirements of high volume manufacturing of electronic assemblies. Supported wave solder and assemble processes. Assisted in the development of a complete manufacturing plan for product compliance to these customer requirements. Implemented various MRP, JIT, lean and continuous improvement projects that are intended to reduce inventory, improve quality and addressing all customers concerns.

Quality EngineerDesigned and implemented total quality plans to ensure compliance to customer requirements and address field failures for electronic assemblies.  Implemented new approaches to
maintain and improve quality reduce manufacturing costs and address continuous improvements. 
Taught various SPC and 8-D problem solving classes.

Supervisor/Electronic TestResponsible for the screening, hiring and supervising of hourly testers to ensure electronic assemblies conformed to customer specifications.  Responsible for meeting cost, safety, OSHA requirements, quality and schedule commitments.  Also, provided hands on trouble shooting support for the testing of controls.

Senior Test EngineerResponsible for total set up of a new facility for testing of electronic control,
Cables and sub- assemblies, Coordinating plant start-up, test equipment transfers from other facilities, training and supervision of hourly operators, and trouble shooting of electronic controls.

1997-1999 Contract Trainer-Provided Basic and Advanced training in areas of SPC, 6 Sigma, Black Belt, QS9000 and Quality Systems to Tier I & II supplies in the automobile industry.

1979-1983 Project Manager, G.T.E. Managed projects responsible for the new construction and expansion of plant and equipment for telephone equipment.  Performed engineering and facility studies to determine capacity and necessary expansion. Managed all aspects of plant and facilities management. Supervised and/or performed engineering economics studies capital recovery and depreciation studies. 
                                   
1978-1979 Quality Engineer/Supervisor, I.T.T Responsible included technical support of incoming and in-process quality assurance in the manufacturing of military radios and communications equipment.  Job functions included developing and maintaining quality policies and procedures, training and supervising hourly inspection personnel and coordinating quality procedures with vendors.          
                                   
1974-1978 Test Equipment Engineer, Magnavox
Responsible for the design of test equipment necessary for the test of UHF & VHF radios in a high volume-manufacturing environment.  Received various awards for cost effective designs.

1969 -l974 Quality Control Engineer, Westinghouse Electric Performed support functions in the quality control department to ensure conformance to required specification in the manufacturing of printed circuit boards for electronic controls.  In this capacity performed vendor surveillance and audits, wrote and maintained all quality instructions for incoming inspection, and supervised/trained the hourly inspectors in the incoming inspection department.

Teaching Experience

CQE Refresher Course
                                   
IVY Tech – 10 years
Quality System         
SPC

ISO/QS9000

Operations Management

Inventory Management

Project Management – PERT & CPM
                                   
Purdue University – 10 years
Material and Process
Basic Machining
Plant Layout and Facility Design
Techniques of Maintaining Quality
Basic & Advanced Statistical Quality Control
Basic Metrology

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