SUMMARY OF QUALIFICATIONS• Highly motivated and experienced change agent manager with accomplishments in all facets of document management for ISO Certified & FDA Regulated Medical Device Companies.• Outstanding leadership abilities; able to balance multiple changing priorities and projects in dynamic environment with proven track record in delivering value.• Successfully driven positive organizational change through process simplification, tools implementation, and focused compliance tracking, thereby reducing cost and increasing company value.• Hired and motivated direct reports to optimize their true potential.• Adept at GMP Quality System Regulations and Federal Regulation Adherence (21 CFR Part 820/21 CFR Part 11)TECHNICAL SKILLS• Document Control Processing and Change Control Management• Quality Systems Life Cycle Records Management & Retention• Design Control & Design Change processes related to Research & Development• Quality Assurance, Regulatory Adherence, Risk Assessment & Management• Windows 2000 & XP Professional, Microsoft Office products (Word, Excel, PowerPoint, Project), Lotus Notes, Agile product collaboration and quality management tool.Specialties: • 20+ years experience working with healthcare and medical device companies• Personally participated in numerous BSI and FDA audits • Proven multi-tasking capabilities with strong ability to plan, prioritize and manage complex projects under aggressive timelines with no supervision required.• Strong leadership skills providing day-to-day direction of priorities and optimum through put enabling my direct reports to succeed and achieve their goals.