October 1998 - Present•Implemented J.D.Edwards Product Data Mgmt. system. Major division resource for coding and converting of all components, bills of materials, material routing, sales reporting codes, commodity classifications, work ctrs, unit of meas.conversion tables, item/supplier relationships/restrictions, costs coding, tracked materials, etc. Responsible for updating Quality System Procedures and Documenting new system process. • Implemented QUMAS DocCompliance and Master Control electronic document control systems. Instrumental in defining & coding document hierarchy structures, groups, privileges, training module, change request categories and review/approval panels. • Design, documentatn, approval and implementation of medical device labeling ensuring compliance with FDA. EEA (Europe) Medical Device Directives, ISO Standards, Regulated Countries Requirements (ROW) and Corporate Policy primary labeling required-elements. • Responsible for design, documentation, approval, translation process and implementation of information for use booklets in twenty eight languages – inclusive of creation and development of Robohelp HTML online help system.•New product development team member ensuring compliance with internal and external documentatin requirements.• Division CE Mark Coordinator- preparation and maintenance of European Government submissions (Technical Files. Int'l Design Dossiers, Canadian Licenses, Declarations of Conformity and International Regulatory Release documentation. •Implementation of EasyLabel Windows-based labeling software program, which utilizes a large percentage of graphic file formats as variable database linkages. Working knowledge of barcoding symbology variations and requirements.•Key participant in FDA GMP Compliance Audits, Applications Integrity Process Audits, and ISO Quality System Certification Audits. • Documentation of Departmental Procedures and Control of Labeling Computer Database procedures.

July 1994- Feb 1996 Bard Cardiology / USCI Division Billerica, MA Document Control Supervisor •Supervised ISO 9001/ EN96001 Certified Document Control Department, Quality Records Department (Technical Data Center) and Sterility Lot Release Department ensuring compliance with FDA GMP Regulations. •Managed systems required for the Creation, Maintenance, Distribution and retrieval of controlled documentation used to manufacture. Inspect, package, purchase and distribute medical products. •Responsible for maintaining Bill of Materials systems integrity. •Key participant in FDA GMP Compliance Audits. FDA (AlP Applications Integrity Process Audits) and ISO Certification Audits. •Responsible for the creation/revision of Quality and Departmental Operating Procedures. •Responsible for department performance tracking reports & complete budgetary responsibility for Department•Responsible for career development and performance appraisals for 15 employees.

• Responsible for the creation of documentation requirements for new product introduction ensuring compliance with GMP regulations and corporate documentation standards. • Responsible for training Engineering Department on Corporate/Divisional documentation requirements/standards.

New Product team member responsible for ensuring adherence to Corporate/Divisional New Product Implementation Quality procedures. • Consolidated multiple projects schedules and current status' for input into a centralized reporting system for project tracking highlighting potential gates, resource issues. etc. to management. • Responsible for developing production plans for new product engineering test builds. • Responsible for authoring and development of Publications / Reference Manuals for Management and Engineering: New Product Implementation Reference Manual & USCI Products Overview Manual.

Various positions held during early years at USCI Division of C. R. Bard, Inc.

Three YearsHonorable Discharge