1. ALAN M. DeSANTIS
11025 Sunshine Drive
Chardon, Ohio 44024
Home (440) 357-8617 Cell (440) 840-3984
isoalan@yahoo.com
CAREER SUMMARY
Vice President of Quality Assurance and Regulatory Affairs with extensive knowledge and experience in quality
systems and medical regulatory affairs including, military, nuclear, telecommunications, ISO 9000, ISO 13485 and
FDA’s QSR and other national regulations.
EXPERIENCE
CODONICS INCORPORATED , Middleburg Heights, OH – 2003 to present
Global leader in image documentation solutions for the medical industry.
Vice President of Quality Assurance and Regulatory Affairs
Overall responsibility for the Quality System Operation and coordination of meeting Regulatory Affairs.
Manage the Quality Assurance Department and maintain the company quality program in accordance with ISO
9000 / ISO 13485, FDA GMP and other regulatory requirements.
Lead Auditor responsible for performing and coordinating audits, internal and external. Reports to the President
of the Company. Manages three direct reports: Quality Assurance Manager, Quality Specialist and Data Analysis
and ten quality inspection personnel.
> Implemented total quality systems to ISO 13485 and Quality System Regulation (QSR) for the Medical
Device Industry, meeting FDA requirements.
> Obtained Certificate of Foreign Government allowing product to be shipped outside the United States.
> Established an in-house knowledge base of regulatory requirements in both domestic and international
regions.
MARCONI SERVICES, North Ridgeville, OH – 2000 to 2002
Global provider of service solutions and support for high performance communication networks.
Quality Systems Manager
Managed Total Quality System for four facilities, including ISO 9001 certification and meeting intent of TL 9000.
Performed internal quality auditing and training within company. Reported to Director of Quality. Supervised two
direct reports: quality specialist and corrective action engineer.
> Implemented total quality systems to ISO 9001; obtained certification for four facilities throughout
United States.
> Implemented programs to track sub-contractors' performance to ensure they met quality requirements.
> Created Lotus Notes corrective action and preventive action system, eliminating four stand-alone systems
into one user-friendly system.
LIBRA INDUSTRIES, INC., Mentor, OH – 1995 to 2000
Full-service contract manufacturer with test services for printed circuit board assemblies and electro-mechanical
subassemblies serving the medical, industrial control and aerospace markets.
Corporate Quality Assurance Manager
Responsible for total quality organization: ISO 9002 certification, QS 9000 and AS 9000 intent. Developed cost
of quality and quality training programs. Supervised 14 direct reports: two quality supervisors, six inspectors, two
quality engineers, two receiving inspectors and two document control specialists.
> Implemented total ISO 9000 program for two facilities and achieved ISO certification.
Alan M. DeSantis, Page Two

2. > Reduced returned materials to under .5% from 15% through vendor audits and quality analysis of defects.
BAILEY CONTROLS COMPANY, Wickliffe, OH – 1978 to 1995
Global corporation and member of ABB Group, designs and manufactures microprocessor-based controls for
power generation, pulp and paper, chemical and materials, food and beverage and marine industries.
Manager, Procurement Quality Control – 1990-1995
Procured quality operation and auditing on worldwide scale. Engaged in all aspects of procurement quality
function. Designed, implemented and serviced total quality program in compliance with government regulatory and
customer requirements (ISO 9000, 10 CFR 50 Appendix B and MIL-Q-9858). Supervised Quality Procurement,
Materials Lab and Inspection Receiving departments.
> Directed successful out-sourcing of $3 million in printed circuit boards, reducing per board cost by 20%.
> Reduced receiving defects from 30% to less than 3% through quality auditing and vendor awareness
programs.
Quality Engineering Supervisor – 1978-1989
Responsible for electronic assemblies and eight direct inspectors.
EDUCATION
Bachelor of Science, Business Administration, Edison State College, Trenton, New Jersey
Associate Degree, Applied Business, Lakeland Community College, Mentor, Ohio
Two-year Technical Certificate, Electricity and Electronics, State of Ohio
PROFESSIONAL DEVELOPMENT
- ISO 13485 Training Course
- ISO 14001 Training Course
- ISO 9000 Series Training Course
- TL 9000 Quality System Overview
- Techniques for Auditors
- PowerPoint Level II Training
- Leadership "ZM 2000", Lakeland Community College Center for Business
CERTIFICATIONS
- Certified Lead Auditor, ISO 9000, TL 9000 and ISO 13485 Quality System Auditing
- Certified Lead Auditor, Nuclear ANSI N45.2.23
- Certified Facilitator for TQM
ASSOCIATIONS
- Regulatory Affairs Professional Society
- American Society for Quality
- IPC Committee Member, National Standard
- Surface Mount Technology Association