2013 -
2017 Vice President R and D, Quality Assurance and Regulatory Affairs @
2006 -
2013 Quality Director @
2006 -
2013 Quality Director for Global Product Control and Sterilization @
2002 -
2006 Vice President of Operations @ Blue Torch Medical Corp.
1997 -
2002 Director of Operations @ UroMed Corp
1992 -
1997 Assoc Chief Biomedical Eng. @
Michael Moniz Education
Northwestern University
Master of Science (Bioengineering and Biomedical Engineering)
1989
-
1990
Boston University
Bachelor of Science (Aerospace, Aeronautical and Astronautical/Space Engineering)
1984
-
1988
Boston University
Bachelor of Arts (Chemistry)
1984
-
1988
Michael Moniz Skills
Medical Devices
ISO 13485
CAPA
Design Control
Quality System
FDA
Validation
Quality Assurance
GMP
V&V
Design of Experiments
Regulatory Affairs
Process Improvement
ISO 14971
FMEA
Biomedical Engineering
Lean Manufacturing
Six Sigma
Development
Verification and Validation V&V
Regulatory
Corrective and Preventive Action Capa
u.s. Food and Drug Administration Fda
Business Process Improvement
Research
u.s. Food and Drug Administration
Verification and Validation
Corrective and Preventive Action
Michael Moniz Summary
Michael Moniz, based in Waltham, MA, US, is currently a General Manager of Operations at SatioDX. Michael Moniz brings experience from previous roles at SatioDX, ABIOMED Cardiovascular Inc, Microline Surgical and Boston Scientific. Michael Moniz holds a 1989 - 1990 Master of Science in Bioengineering and Biomedical Engineering @ Northwestern University. With a robust skill set that includes Medical Devices, ISO 13485, CAPA, Design Control, Quality System and more. Michael Moniz has 2 emails and 1 mobile phone numbers on RocketReach.
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