Lead Auditor and Consultant @ (April 2019 - Present)
Director of Quality and Regulatory Compliance @ (June 2014 - February 2026)
Director of Compliance @ (January 2024 - January 2026)
Strategic Consultant @ (August 2015 - August 2025)
Director of Quality and Regulatory @ (January 2013 - May 2014)
Regulatory Engineer @ (September 2010 - January 2013)
Design Quality Engineer @ (March 2008 - September 2010)
Product Development Engineer and Consultant @ Rheomedix, Inc (February 2006 - October 2008)
Adjunct Instructor and Research Assistant @ (November 2006 - March 2008)
Project Engineer and Founder @ Skryba LLC (January 2004 - March 2008)
Electronic Staff Engineer @ (September 2005 - March 2006)
Research Assistant @ (January 2002 - June 2005)
Electrical Engineer @ Maida Engineering (May 2002 - December 2003)
RF Design Engineer @ (March 2001 - September 2001)
Requisition Engineer @ (March 2000 - September 2000)
Michael Zagorski Education
Drexel University
MS (Biomedical Engineering)
Drexel University
MS (Engineering Management)
Drexel University
BS (Electrical Engineering)
Michael Zagorski Skills
Design Control
Quality Engineering
ISO 13485
Product Development
Quality Auditing
Engineering Management
Prototyping
Research
Software Quality Assurance
Start-ups
Concept Development
eHealth
Medical Devices
FDA
CAPA
Root Cause Analysis
Biomedical Engineering
Quality Systems
GMP
Quality System
Cross-functional Team Leadership
Process Improvement
Electrical Engineering
Quality Control
Testing
FMEA
ISO 14971
Electronics
Quality Management
Regulatory Affairs
R&D
V&V
Continuous Improvement
Design of Experiments
Engineering
Embedded Systems
DMAIC
Design for Manufacturing
Minitab
Process Simulation
Product Design
ISO
Labview
21 CFR Part 11
Six Sigma
Supplier Quality
Manufacturing
Quality Assurance
CE marking
U.S. Food and Drug Administration (FDA)
Customer Service
Public Speaking
Strategy
Start Ups
Cross Functional Team Leadership
Digital Electronics
Regulatory
u.s. Food and Drug Administration Fda
Analog
Strategic Planning
Management
Ultrasound
u.s. Food and Drug Administration
Michael Zagorski Summary
Michael Zagorski, based in Pittsburgh, PA, US, is currently a Quality and Regulatory Consulting at RegAdvisium LLC. Michael Zagorski brings experience from previous roles at Quality Auditing LLC, ImPACT Applications, Inc., Riverside Insights and EBG Advisors, Inc.. Michael Zagorski holds a MS in Biomedical Engineering @ Drexel University. With a robust skill set that includes Design Control, Quality Engineering, ISO 13485, Product Development, Quality Auditing and more. Michael Zagorski has 2 emails and 3 mobile phone numbers on RocketReach.
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