David Letteri's Resume

David Letteri

Director of Quality Assurance/Regulatory Affairs@Aerobiotix, Inc.

Nationality

Summary

Director of Quality Assurance & Regulatory Affairs | Over 25 Years in Medical Devices | Specializing in ISO 13485 & Quality Management Systems. 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

Work experience

Director of Quality Assurance/Regulatory Affairs
Aerobiotix, Inc.
2018.10-Current
(8 years)
Advance Quality Planning Manager
Norwood Medical
2017.08-2018.09
(a year)
QA/QC Director
X-spine Systems, Inc.
2015.07-2017.08
(2 years)
VP, Quality and Regulatory
NovoSource, Inc.
2012.08-2015.06
(3 years)
Quality Assurance/Regulatory Affairs Manager
X-spine Systems, Inc.
2010.06-2012.08
(2 years)
Quality Director
RAM Precision Industries/RAM Medical Solutions
2007.10-2010.06
(3 years)
Quality Director
Leis Medical, Inc.
2002.09-2007.10
(5 years)
Quality Manager
Heidelberg Web Systems
1999.01-2002.09
(4 years)
Quality Manager
Sheridan Systems
1997.01-1998.01
(a year)
Quality Engineer
Harris Graphics
1987.01-1996.01
(9 years)
Quality Engineer
Square D Company
1984.01-1987.01
(3 years)