Position:
Senior Director of Quality & Regulatory at Precision-Spine, Inc.
Location:
Greater New York City Area
Work:
Precision-Spine, Inc.
- Pearl, MS since Jun 2012
-
Senior Director of Quality & Regulatory
Contract Medical Manufacturing, LLC
Jul 2009 - Feb 2012
-
Director of Quality/Engineering
Charles Vassallo Engineering Consulting
Jun 2008 - Feb 2010
-
Principle
MedicalCV
Apr 2007 - Jun 2008
-
Director of Development
Charles Vassallo Engineering Consulting
Sep 1994 - Jun 2007
-
Principle
Restore Medical
1999 - 2001
-
Consultant
Davis + Geck
1991 - 1994
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Senior Project Manager
Education:
University of Bridgeport 1975 - 1976
BS, Electrical Engineering
University of Bridgeport 1973 - 1975
BS, Biomedical Engineering
Skills:
Design Control, Medical Devices, 510 K, Budgeting, Quality Systems, Manufacturing, ISO, Engineering, Quality Engineering, Quality Assurance, Cost Reduction, ISO 13485, Biomedical Engineering, Process Validation, FDA, CAPA, QSR, Product Development, Commercialization, Cross-functional Team Leadership, ISO 14971, Validation, Start-ups, Product Management, CE marking, GMP, Product Launch, DOE, Quality Auditing, Lean Manufacturing, FMEA, Solidworks, PMA, Quality Management, Continuous Improvement, Electronics
Interests:
Golf, cooking, sports, woodworking, home improvements
Honor & Awards:
AAMI Certified Clinical Engineer
Patents; Incorporation of electrosurigal energies to ultrasonic member, electrosurgical boot for endoscopic instruments, tongue based implant for airway obstruction