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 retail-
marketing 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