Shawn Fitzgerald
Quality & Regulatory Leader | Medical Device & Pharma | Global QMS Transformation, FDA/ISO 13485/MDR Compliance
- Role
- Quality Managment Systems Expert at USDM Life Sciences
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Shawn Fitzgerald
As an accomplished Quality and Regulatory Affairs leader with over fifteen years of…
Experience
Quality Managment Systems Expert
Oct 2024 — Present · US
USDM Life Sciences is the leading global technology consulting firm focused on digital transformation, regulated and unregulated data management and compliance solutions for the world’s leading and emerging biotechnology, pharmaceutical and medical device companies.As Quality Management Systems Subject Matter Expert, I’m responsible for integrating Quality Mangement Systems from three global divisions into a common QMS including systems, processes and documentation. Spearheaded $6M global QMS harmonization for Enovis (Class Orthopedic Surgical Implants), integrating three QMSs and eQMS platforms, achieving full MDR, QMSR, ISO 13485, and MDSAP compliance while reducing costs by 30%. Developed strategic Quality Plans for three global business units, streamlining operations and leaned quality processes enabling 10% workforce reduction. Led cross-functional teams, managing resources, schedules and budgets in complete rewrite of QMS ensuring MDR, QMSR, ISO 13485 and MDSAP compliance Optimized Design Controls and implemented ISO 14971 Risk Management to accelerating speed to market
Education
Virginia Tech
BS, Mechanical Engineering
1990 — 1994
Virginia Tech
Master of Science (MS), Mechanical Engineering
1994 — 1996
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