David Letteri
Director of Quality Assurance & Regulatory Affairs | 25 Years in Medical Devices | Specializing in ISO 13485 & Quality Management Systems
- Role
- Director of Quality Assurance Regulatory Affairs at Aerobiotix
- Location
- Dayton, OH, US
- LinkedIn followers
- 500 followers
About David Letteri
Quality professional with 30 years of experience in manufacturing and quality - electro-mechanical, capital equipment, and Class 1 and Class 2 orthopedic medical devices. Leadership positions as Manager, Director, and Vice-President of Quality Assurance and Quality Control. Six Sigma Green Belt. Certified Manager of Quality and Organizational Excellence through the American Society for Quality.Specialties: Six Sigma Green Belt, Quality Management Systems (ISO 9001, ISO 13485, FDA GMPs), Systematic Problem Solving, Team Building
Experience
Director of Quality Assurance Regulatory Affairs
Oct 2018 — Present · Dayton, OH, US
Education
Rose-Hulman Institute of Technology
Bachelor of Science, Mechanical Engineering
1978 — 1983
Skills
- Supplier Quality
- Root Cause Analysis
- Orthopedic
- U.s. Food and Drug Administration (Fda)
- Quality Assurance
- Design for Manufacturing
- Continuous Improvement
- Quality System
- Regulatory Compliance
- Lean Manufacturing
- Quality Management
- Spc
- Team Building
- Manufacturing
- Iso
- Business Process Improvement
- Fda
- Six Sigma
- Quality Auditing
- Iso 13485
- Dmaic
- Manufacturing Engineering
- Leadership
- Iso Standards
- Process Improvement
- Medical Devices
- Capa
- Quality Control
- Gmp
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