JAMES M. MOORE
6362 HICKORY BARK DRIVE
LOVELAND, OHIO 45140
[Send email to request phone number] 75-9043
[Send email using form at bottom]
PROFESSIONAL PROFILE
Quality engineering with extensive experience in positions of increasing
responsibility involving a variety of manufacturing companies. Background
includes a record of accomplishments in the following areas:
Geometric Dimensioning and Tolerancing Production Part Approval Process
(PPAP)
Statistical Process Control (SPC) Vendor/Supplier Relations
Measurement System Analysis (MSA) ISO13485/Military Specs./cGMP-QSR
Design of Experiments (DOE) Failure Mode Effects Analysis (FMEA)
PROFESSIONAL EXPERIENCE
MORAINE MOLDED PLASTICS / Cincinnati, Ohio ---Quality Assurance Manager /
Engineer 1/03-Present
Coordinate with Engineering & Manufacturing, validated designs and assure
trouble-free manufacturing
Perform analysis of product failures, recommend and implement Corrective and
Preventative actions.
Supervise three (3) hourly inspectors, two (2) technicians and one (1)
engineer
Contribute to making the supported Program Manager (The Voice of the Customer)
successful.
Deliver on time a product (hardware, software and documentation) that meets
customer
expectations in a matrix-supported, team environment.
Use Six Sigma tools (DMAIC process) to demonstrate a robust, problem solving
process.
Institute a disciplined SPC program for assigned programs (in-house) along
with key suppliers
Develop and maintain trusting relationships with customer counterparts to
understand customer
needs and to ensure a positive, team-oriented working environment
Develop and maintain trusting and responsive relationships with internal
customers, e.g., hourly and lead personnel on the manufacturing floor as well as
program and senior management.
Management Representative for compliance to ISO 9000:2000, ISO 13485:2003 and
TS 16949
ETHICON ENDO-SURGERY, J & J / Cincinnati, Ohio --Senior Supplier Quality Systems
Engineer 1/96 1/03
Prepare, conduct, monitor, report on supplier performance to assess compliance
to GMP/QSR, ISO9000:2000, ISO13485:2003 Ethicon Endo-Surgery standards and
provide key performance information to the department managers and senior
management.
Provide statistical support and expertise in DOE and analytical problem
solving techniques to Manufacturing, Technical Services, and Product Development
to minimize sampling/scrap/rework/excess labor and waste; assess reliability and
risk based on data
Identify root cause of problems implement. CAPA actions.
Perform FMEAs; review Material Specifications, Control Plans, Gage R & R
Studies and Capability assessments.
CIBA VISION / Atlanta, GA. ---Senior Validation QA Engineer
11/90-1/96
Provide statistical support to Quality Assurance Engineering, R& D and
Manufacturing
Develop Installation/Operational/Process/Product Qualifications
Validation/Revalidation Protocols
Responsible for monitoring and administering Complaint/Product Information,
Incident Reporting, Return Goods Issues.
Implemented Statistical Process Control Tracking and Process Capability
Analysis
GENERAL ELECTRIC / Louisville, Kentucky---Advanced Manufacturing Engineering /
Metallurgical Specialist 7/82-11/90
Direct responsibility for inspection of all incoming raw materials,
fabrication, welding and finishing operations.
Metallurgical , metagraphical analysis, strength of materials, physical
properties testing, and failure analysis
Introduce X-ray fluorescence spectrometry to provide scrap avoidance of
$360,000.
EDUCATION
Bachelor of Science, Mathematics / University of Louisville / Louisville,
Kentucky 1982
Certified ASQ-CQE & CQA / Six Sigma Process Excellence Black Belt / Certified
RAB Quality Systems Auditor
COMPUTER SKILLS
ALL Microsoft Office Programs Paradox
Minitab Stat graphics for Windows
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