Solutions Architect | Apr 2015-Present• Design, develop and optimize workflows for customers deploying Sparta Systems’ industry leading Trackwise ® Enterprise Quality Management System (eQMS) software. • Collaborate with internal and external resources to identify best practices for Sparta Systems product design/development activities as well as for analyzing customer workflows. • Subject Matter Expert, providing guidance to Sparta Systems Product Development group regarding regulatory and ISO based requirements.• Conduct product demonstrations of configured best practice workflows for Audit, CAPA, Regulatory Product Registration, Complaint Management and other business processes requiring analysis, tracking and closure.• Perform quality management system webinars and presentations to national/international audiences.

• American Society for Quality (ASQ) Sr. Member & Certified Biomedical Auditor (Cert# 1504); also, CQA June 1997-June 2003• Publications & Featured Presentationso FDANews-Webinars: How to Prepare for an FDA Inspection; Best Practices for Compliance with ISO 9001 Standards-A Context for Learning Organizations; o Sparta Systems – Webinars: Getting Ready for the Medical Device Single Audit Program (MDSAP); o Medical Design & Outsourcing Magazine – Source for Article: Medical Device Reporting: Your Burning Adverse Event Questions Answered, [source & byline]• Registrar Accreditation Board (RAB) Accredited ISO 9001 Auditor: October 1996-October 2002• Underwriters Laboratories Certified Quality Management Systems Lead Assessor for Preliminary, Registration, and Continuous ISO 9001 / TS-16949/ QS9000 assessments: January 2000 • Underwriters Laboratories Certified ISO 9001 / TS-16949 / QS9000 Design Systems Lead Assessor: December 2000• Bausch + Lomb Certified ISO 9001 / ISO 13485 / FDA 21 CFR 820 Lead Global QMS & Compliance Auditor: March 2010• Automotive Industry Action Group (AIAG) ISO TS-16949 Certified Lead Auditor: 2000-2003• Toastmasters International Member

• Planned and executed 54 supplier compliance during Aug-Dec 2006 to remediate a delinquent program.• Conducted over 850 management system assessments to ISO and Regulatory Agency standards.• Extraordinary scope of industry and management system exposure.• Directed implementation of MRP-based, hard controls for changes to approved supplier list.Re-designed and launched Bausch + Lomb Internal Auditing Program compliant to the medical device requirements of five (5) countries: EN ISO 9001 & 13485 / FDA 21 CFR 820 / Japanese Pharmaceutical Affairs Law (JPAL) / Canadian Medical Devices Conformity Assessment System (CMDCAS) / EU Medical Device Directive (MDD) and Brazilian ANVISA standards:• Managed IQ, OQ, PQ process for Coordinate Measuring Machine and SmartScope visual measurement system.• Developed and deployed 165 page internal auditing matrix. Includes requirements from US, Brazil, Canada, Japan, and EU medical device regulatory agencies. Provides for clear documentation of evidence reviewed during the internal audit. Reduced review time by more than half over previously used methodology.• Implemented auditing matrix at multiple sites; conducted internal GxP compliance audits across the surgical business unit.• Matrix received positive feedback from B+L Global Compliance as well as FDA regulatory inspectors.• Immediately reduced non-conformances against the B+L internal audit program to negligible numbers.Successfully completed long-term assignment in Southern California: • Assigned to Los Angeles, (from St. Louis), to spearhead this effort. • Achieved objectives in less than targeted 12- week completion window. • Project required recruiting, resource planning, training and project management skills as well as an ability to lead people to execute and obtain results while faced with incredibly difficult circumstances.• Leadership recognized across the Global B+L organization.

Lead ISO 9001 & TS16949 Management System Assessor – (Contract based) | Aug 2005 – Aug 2006Lead ISO 9001 & TS16949 Management System Assessor – (Full Time) | Jun 1997 – Oct 2001Plan, schedule, conduct and report management system audits for compliance to international quality standards:• Planned & Conducted in excess of 600 management system assessments during tenure with Underwriters Laboratories.• Trained new assessors and reviewed performance of existing assessors.• Maintained excellent rapport with clients. Recognized for remaining true to the intent of the standards.• Excellent track-record of timely closure of all projects (audits).• Managed teams of auditors – providing guidance and, at times problem resolution while maintaining excellent customer service with clients.• Review and assess management systems to international standards for quality, identifying areas for needed improvements• Piece together relationships and correlations between multiple inputs from complex management, Design and manufacturing systems. • Exercised good judgment and sound counsel when communicating with clients regarding their level of compliance.