Proven executive with over 20 years of organizational and program management experience, including the last 15 years in 21CFR Part 820 FDA environment.
- Effective Leader providing vision, clear direction and engagement to empower people to maximize their impact
- Seasoned Manager experienced in P&L oversight, strategic planning, negotiation, budgeting and staffing in both startup and growth organizations.
- Versatile Contributor experienced in establishing FDA compliant quality management systems and gaining ISO13485 certification while applying Lean Manufacturing and Six Sigma Skills.
- Program Manager for Product Development of immunoassay diagnostics and automated process equipment.
CORE COMPETENCIES
• Organizational Leadership
• FDA Quality System Regulations
• Complex Problem Solving
• Program Management
• ISO13485 and CMDCAS
• Building Collaborative Teams
• Product Development
• IVD and MDD Regulations
• Lean Six Sigma Manufacturing
Listed skills include Medical Devices, Manufacturing, Six Sigma, Fda, and 39 others.