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, Quality System development and management, ISO Systems and / internal auditing, Technical files (TF) development, submission and support, ISO 13485, ISO 9001, ISO 14971, and ISO 17025 support, Quality System Regulations support, FDA 483 Warning letter and remediation support, ISO registration support, Supplier management of domestic/ overseas manufacturers, Complaint handling management, Document control management, Inspection systems and controls, Calibration systems, 510(k) development, submission, and support
Medical Device manufacturing support

SUMMARY

Quality Management Engineering Expert Witness in the field of supplier audits, QMS development and implementation for small and startup ventures, Quality Systems development, implementation. Assistance in obtaining ISO 13485 and 9000 registration. also conduct internal & supplier audits, quality initiatives, develop and support CAPA and complaint analysis, MDSAP (Medical Device Single Audit) audits, gap assessment, change control, risk management, develop quality systems and policies and providing necessary training and support FDA 483’s and audits.

EXPERIENCE

1999 -Present Owner/President Technical Training & Consulting. Cincinnati , OH
Own a consulting service that provides quality engineering /management support for small and start up manufactures. Service include ISO registration support, gap assessment, QMS development & support, FDA support and conducting internal and supplier audits.

2007 – 2014 Quality Specialist Previously Quality Manger (retired 11/2014) Develop and managed the implementation quality plans necessary to ensures the transfer new products to Low Cost Countries conform to established quality standards and compliancy with Quality System Regulations (QSRs) including 21 CFR 820, ISO 9000, ISO13485. Participated in various lean management initiatives. Additionally, conducted internal and supplier audits and supported IQ/OQ/ PQ activities and supplier development initiates.

2001-2007 Medtronic- Senior Quality Supplier Engineer – Responsible for establishing and conducting a supplier audit program to insure supplier conformance to all ISO/ FDA & corporate requirements. Functions included managing and performing audits to ensure compliance to ISO, FDA, requirements. Developed and implemented audit procedures, interface with all suppliers relative to quality system requirements and manage supplier development. Responsible for performing Gap analysis of Supplier Quality Systems to FDA 820, ISO 2000 & 13485 requirements. Develop a supplier certification program and enhanced the supplier evaluation program. Managed the Supplier Audit Program and maintained supplier audit reports, supplier qualification documentation and supplier certifications. Conducted more than 500 supplier audits while traveling 50 to 75 %.

2000-2001 Midwest Stamping – Senior Quality Engineer – Assist in supporting TS 16949 quality requirements and ensuring 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 Pareto analysis, 8-D problem solving and root cause analysis techniques.

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 various process Improvement programs.

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 and relationship building concepts and support Six Sigma initiatives, lean manufacturing, empowerment, problem solving and decision-making abilities of the workforce.

Senior Manufacturing Engineer-Developed and implemented plans to meet all customer requirements of high-volume manufacturing of electronic assemblies. Participate in various CI initiatives. Supported wave solder and assemble processes. Attended a SIXSIGMA Training academy. 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 Manager- Manager /designed 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 Test-Responsible 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.

1997-1999 Contract Trainer
Provided Basic and Advanced training in areas of SPC, APQP, MSA, PPAP, 6 Sigma, Control
plans D & T, Plan 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 (summer Intern), 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.

EDUCATION

Bachelor of Electronic Engineering/Minor Industrial Engineering, University of Dayton,1973

ISO 2009—Lead Auditor Certification

CORPORATE TRAINING

ASQ CQA Trainer

ISO 13485 Lead Audit training
Internal audit training
GE- BLACK BELT (Six-week training)
GE- BLACK BELT TRAIN THE TRAINER Course
SPC, APQP, MSA, PPAP Training
Supervisory Training
Team Building
Project Management – PERT
6 Sigma-Black Belt
Black Belt-Train the Trainer
ISO/9000 Overview

TEACHING EXPERIENCE

CQE Refresher Course

IVY Tech – 15 years
Quality System
SPC
ISO/QS9000
Operations Management
Inventory Management
S P C- Process Control
Project Management – PERT & CPM
Quality Management
Six Sigma Trainer

Purdue University – 15 years

C Q E Certification Training
Basic & Advanced S P C
APQP, PAPP & FEMA Training
Basic Manufacturing Operation
Plant Layout and Facility Design
Techniques of Maintaining Quality
8D and Mistake Proofing
Basic & Advance Measurement Systems Analysis (MSA)
Basic Metrology

 

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