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Francis ("Andy") Guidry 571 Canterbury Drive * Plover, Wisconsin 54467 Cell: 715-347-7090 * Email: fg551024@westpost

.net Senior Manager, QA Engineering Manufacturing and Quality Systems: Medical * Electrical * Consumer Goods Accomplished Quality Manager with exceptional depth and breadth of experience in high-volume manufacturing and distribution environments. Special expertise in q uality standards for medical-device, and packaged-goods companies. Exceptional s trengths in three areas: * Creativity: Designed or suggested many successful product improvements, includ ing a SCSI hard-drive tooling patent, which eliminated a repetitive motion probl em invention. * Problem Solving: Analyzes and improves process, process control, and quality s ystems. Develops sampling plans and evaluates manufacturing/quality systems, too ling and specs. * Team Leadership: Natural leader who builds and motivates effective teams. AREAS OF EXPERTISE * Quality, Engineering, Information Systems & Production Management: Implement D ivision level quality programs for ISO 9001:2000 and 13485:2003. Direct site Qua lity Managers and Supplier Quality Engineers. Managed Quality Operations for Pro duction, Site, and Engineering & Information Systems. * Procurement Quality / Manufacturing Engineering: Supplier evaluation, Technica l Interfaces, problem evaluation and resolution, system documentation, and train ing implementation. Certified ISO 9001:2000 Auditor. PROFESSIONAL EXPERIENCE RR DONNELLEY - GLOBAL TURNKEY SOLUTIONS, Plover, WI 1995-Present Formerly Banta Global Turnkey - a global Supplier Chain Management (SCM) company that purchases components, assemblies them into packages, and handles logistic s and distribution. Products include: medical devices, SCSI hard drives, comput er components, country kits, modems, retail electronics, gift cards, and retailmarketing displays. Approx. 6,500 employees, $400 million sales, and 10 global s ites. Quality & Engineering Manager | Security Manager (2008-Present) Tasked to implement systems to support a major new medical device customer: main tain ISO 9001 & ISO 13485 registration, and register for multi-state pharmaceuti cal manufacturing-distribution licenses. Lead 9 direct reports, including Qualit y Engineers, Quality Engineering Technician, Quality Supervisor, ISO Administer, and Device History Recorder Review Clerks. Manage $1.3+ million budget for qual ity functions such as calibration services, external ISO audit/registration, sec urity systems, and facility cleaning. Job scope * Assign and approve all Corrective and Preventative Action (CAPA) documents, pr ocedures, and specifications for the facility. Review product lines by walking t he production floor and talking to employees. * Set up all inspection standards by reviewing actual product and making final d ecisions in accordance with customers' requirements. * Establish and maintain a Quality Engineering department to support Validation Master Plans for medical device qualifications, process validation protocols, Fi rst Article Inspection, component & process deviations systems and process sampl ing plans. * Establish and maintain a Quality Inspection department for all processes. Highlights * Accomplished medical-device assembly validation for a new customer within a ye ar: * Successful validation led to over 150 jobs to the Plover facility. * Project consisted of 6 assembly lines for over 80 SKUs, including: blood gluco se meter configuration line, high speed, 125/minute, automatic reagent vial labe ling system, and a semi-automatic, 35/minute, reagent vial labeling system. Quality, Engineering & Information Systems Manager (1999-2008) RR Donnelley Global Turnkey Solutions purchased Banta Corp. in January 2007

Designed and implemented a fully functional site IT Disaster Recovery (DR) progr am that cost less than $2,000 to implement and less than $300/month to maintain. Designed quality reports for the facility that met all customer requirements. M anaged newly hired Quality Engineers and Device History Records (DHR) for every production lot. * Co-invented a SCSI Hard Drive Assembly tooling improvement that eliminated a r epetitive motion problem (U.S. patent 6477764 B1). * Recognized as one of two employees who played an instrumental role for a major contract win - a 5 year, worldwide SCSI Hard Drive assembly contract valued ove r $600 million. * Achieved ISO 9000:1994 and ISO 13485:2005 registrations that led to a major co ntract. * Established supplier-management system. Conducted and approved all supplier su rveys in conjunction with the Material Manager. * Moved a major customer's software-assembly process, ordering system (32 differ ent inputs), and fulfillment process without affecting delivery schedules. Reduc ed costs and defect rate within 3 months. Manager of Quality Engineering / Director of Quality (1995-1999) Banta Global Turnkey, LTD Improved QA as in-house consultant and tasked to register all four North America n sites with ISO 9001-1994. Held on-site reviews focused on process, documentati on, and CAPA systems. * Established a new facility that supported a start-up program for a major custo mer. Designed production layouts, trained a new set of employees, established qu ality standards, and set up reporting to ensure compliance with customer require ments. * Set up quality documentation and achieved ISO 9001-1994compliance for 3 site. * Seamlessly transferred a major customer's program from Europe to the U.S. Esta blished European program to meet a major customer's needs. SUMMARY OF ADDITIONAL EXPERIENCE IBM and IBM/ROLM, Various Locations: * Advisory Engineer, Procurement Quality (1989-1995): Collaborated closely with corporate drafting. Directed receiving inspection and process-reliability evalua tions for printed wiring boards, assemblies (SMT, PTH), and solder ball attach p rocesses) * Manufacturing and Quality Engineer-IBM/ROLM (1986-1989): Provided engineering support for quality compliance and production-process development. Supplier Qual ity Engineer for PCB assembly processes and components. EDUCATION Lincoln College, Liberal Arts Coursework Santa Barbara Jr. College, Engineering Coursework AAMI Achievement Certificate for cGMP Training * AMP Institute - Crimp Tooling C ertified