Quality Assurance

Executive Summary

Resourceful, analytical and detail-driven individual with the ability to coordinate the completion of multiple six sigma projects with competing deadlines. Aggressive in identifying and resolving inefficient operational processes utilizing kaizen and six sigma techniques. Strong team leader able to instruct and motivate personnel to achieve optimal quality processes and product delivery while maintaining high safety methods and practices. Reliable follow-through skills, fulfilling all administrative requirements. Clear communicator, both oral and written. Interpersonal skills interface effectively with coworkers, management and customers. Excels in unpredictable and hectic environments.

Professional Background

Cardinal Health Inc., Columbus Ohio Jan 2008 to present

Enterprise Information Technology - Sr. Quality Engineer

• Metrics definition and reporting leader for Information Technology Quality Assurance organization in support of $86 billion pharmaceutical and medical device supply chain network.

• Organized and lead software quality assurance, quality control and risk management organizations in development of key software development quality metrics. Created quality and security assurance dashboards for utilization by IT Senior Vice President and Vice President for operational and strategic decision making.

• Developed and facilitated visual strategic planning method utilized by Senior Vice President of Operational Assurance for 2009 strategic planning. Planning included establishing the priority of key initiatives for greatest impact against 2009 performance goals and identifying quantitative targets to achieve those goals.

Rolls-Royce Energy Systems, Inc., Mount Vernon, Ohio 2004 to 2008

Quality and Business Improvement Manager- Six Sigma Project Sponsor

• Process excellence (Six Sigma) leader for gas turbine power system and oil/gas transmission business unit of 440 employees. Focusing organizational improvement on customer response, compliance to process, and develop of design, manufacture and supplier control processes.

• Managed and mentored two Six Sigma Black Belts and eight Green Belts to achieve quality requirements, cost reduction and cycle time targets for Engineering and Supply Chain delivery processes.

• Achieved 40% annual reduction in cost of nonconformance, representing 2 million dollars in savings annually. Improvements focused on supplier control, supplier transaction and plant level Six Sigma and kaizen projects.

• Implemented a Design for Manufacture system that incorporates supplier process and gage capabilities into upfront design. The system prevents nonconformance on first piece and ensure process capability throughout product lifecycle.

• Quality leader for 12 exempt quality engineering staff and 12 non-exempt employees.

• Solutions Owner for the supply chain segment of the Energy business. Achieved a 50% reduction in raised customer concerns over an18 month period through lean and six sigma initiatives.

• Coordinator of technical response to field issues raised during installation and commissioning of Energy product to remote sites.

• Profit, Loss and Budgetary responsibility for quality improvement personnel, facilities and the reduction of cost of nonconformance impacting an Operating Business Unit of $100 million.

• Control Account Manager for review and release of 160 Business Process and Work Station procedures designed for lean organizational processes.

Fort Wayne Metals Research Products Corporation, Fort Wayne, Indiana 1996 to 2004

Quality Systems Manager-Black Belt

• Developed corporate Six Sigma structure including Steering Committee, project prioritization to measurements of performance, and Black Belt/ Green Belt training and mentoring. Yearly cost savings rate: $500,000/year on $43 million sales volume. $700,000 minimum projected for 2005 fiscal year. Programs include execution of full range of DOE and statistical analysis techniques. Trained quality and engineering personnel for full utilization of Minitab statistical software up through factorial design.

• Developed and implemented quality system for 3 domestic and 1 international medical device manufacturing facilities. Facilities are compliant to system and part qualification requirements of FDA/GMP, ISO 9001/2000, and major medical device manufacturers ( includes Johnson & Johnson, Medtronic, and Boston Scientific).

• Customer acceptance of product increased from 96.5% to 99.5% from 1996-2004. Sales growth during time period-$25 to $46 million per year. Customer base: 500 active customers with 20 key accounts

• Implementation of daily visual tracking system for all corporate departments on their contributions to internal and external acceptance of product.

• Facilitation of executive management strategic planning including market analysis, competitive analysis, definition of strategic issues, and development/execution of key strategic plans.

• Project Management coordinator for organizational improvements. 30 active projects with completion rate of 80 per year.

• Engineering specification review system developed includes cross-functional review of specification, customer negotiation of specification and process design.

• Intellectual property system developed includes organizational trade secret security, laboratory book documentation of technical activities, confidentiality agreements, and corporate strategic efforts relative to internal, customer, and competitive patent and trademark activity.

• Facilitated executive management review of corporate quality system to international and federal standards for world’s leading producer of medical device wire and cables including 4 facilities in 3 years. Certification to ISO 9001:2000 within 6 month of standard release.

• Implementation and certification of new Irish facility to FDA/GMP and ISO 9001/2000 within 6 months of facility start-up.

• Team development and management of 40 process engineering, quality engineering, laboratory services and inspection personnel.

• Coordinator of first article submissions, control plans, root cause analysis, FMEA and cross-functional response to customer and internal quality issues.

• Inventor status on 2 patents : A improved melt practice that increases the fatigue resistance of implantable alloys for cardiac care management and an embedded filament wire that will increase mechanical, corrosion, radiopacity and fatigue performance on biomedical implant wire.

Evenflo Company, Inc., Piqua, Ohio 1994 to 1996

Quality Systems Engineer

• Pre-market, initial production, and post-market evaluation of designed products for proper geometric design and tolerancing, manufacturing capability (primarily plastic injection molding, metal stamping, and harness construction), and child safety.

• Facilitated implementation of juvenile safety products (car seats, stationary activity centers, high chairs, cribs, etc.) quality system to international and federal standards.

• Customer acceptance of product by sales dollar increased from 96.3% to 97.2% from 1994 to 1996 for Average sales -$120 million per year.

• Developed data acquisition, databases, and reports for inspection and customer acceptance data. Managed personnel responsible for evaluating customer returns. Coordinator of root cause analysis.

Elano Corporation: G.E. Aircraft Engines, Xenia, Ohio 1990 to 1994

Quality/Process Engineer

• Manager of foundry inspection personnel performing dimensional product evaluations, surface finish, mechanical properties, x-ray and florescent penetrant inspection.

• Pre-market, initial production, and post-market evaluation of designed aircraft components for proper geometric design and tolerancing, manufacturing capability (primarily cast and CNC machined components), and product integrity.

• Documented and facilitated implementation of aircraft component quality system to commercial and military standards for new-start investment casting foundry division. Process capability included 150 active and 500 possible aircraft components.

• Implementation of GE characteristic verification program which effectively transferred responsibility of meeting and evaluating product characteristics to process owners resulting in 30% increase in foundry throughput. Effort increased operations thoroughness of product evaluation and personnel ownership of process improvement resulting in 30% decrease in rejection at final product inspection.

• Participated in foundry team G.E. kaizen, lean manufacturing programs that included 30% reduction in mold set-up. Introduced stereolithographic resin technique as part of Ohio's Edison Material Technology Transfer Program that reduced development lead-time by 80%.

Howmet Turbine Components Corporation, Hampton, Virginia 1989 to 1990

Quality Engineer

• Facilitated on-site customer surveillance audits of industrial turbine blades. Included presentation of data generated from three dimensional product evaluation, surface finish, mechanical properties, x-ray and florescent penetrant inspection.

Education

Valparaiso University School of Law, Indiana

Juris Doctorate Candidate

Part Time, Focus in Intellectual Property

Credits completed to 2L status: Fall 2000-Spring 2002

University of Dayton, Dayton, Ohio 1995

M.S., Engineering Management

GPA: 3.7 Coursework in Operations Research, Logistics, Automated Design, Statistical Analysis, and Quality Functional Deployment. Master's Dissertation: "The Functional Relationship between Quality System Implementation and Organizational Effectiveness"

The Ohio State University, Columbus, Ohio 1989

B.S., Metallurgical Engineering

Publications

"The Influence of Melt Practice on Final Fatigue Properties of Nitinol Wires." Proceedings of the 3rd International Conference on Shape Memory and Superelastic Technologies. SMST, 2000. Findings resulted in establishing industry benchmark for metallurgically clean nitinol wire.

"Improving implantable cobalt based alloy fatigue life through melt microcleanliness." Annual Medical Device Conference. ASM 2003, 2003

"Measuring the impact of wire surface texture on cell growth and drug eluding coating adhesion." Annual Medical Device Conference. ASM, 2003

"Fatigue Improvement of DFT® Wire Through Melt Chemistry Improvement." Annual Medical Device Conference. ASM, 2004

"Critical Testing Methods for Ensuring Medical Needle Material Stock." Annual Medical Device Conference. ASM, 2004

"Critical Techniques for Torsional Wire Straightening." Annual Medical Device Conference. ASM, 2004

"Utilizing Photoemission Testing to Quantify Wire Cleanliness." Annual Medical Device Conference. ASM, 2004

Professional Organizations

Cardinal Heatlh Premier Toastmasters Club – 08-09 Vice President of Education

Product Development Management Association

American Society of Materials

Certifications and Designations

MoreSteam Ceritified Six Sigma Black Belt 2007

Quality Engineer Certification, American Society of Quality

Certified Black Belt, University of Wisconsin, 2003

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