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Mitch Lewandowski Location
Saint Paul, MN, US
Mitch Lewandowski Work
EVP Quality Assurance @ (February 2026 - Present)
VP Regulatory Affairs and Quality Assurance @ (November 2024 - January 2026)
Vice President, Quality @ (March 2020 - September 2024)
Executive Director of Quality @ (October 2017 - March 2020)
Director Quality Assurance @ (July 2015 - October 2017)
Senior Director Quality Assurance @ (June 2012 - June 2015)
Design Assurance Manager @ (January 2011 - June 2012)
Manager, Quality Assurance @ (July 2007 - December 2010)
Senior Project Manager @ (April 2005 - July 2007)
Sr Technical Operations Scientist @ (April 2003 - April 2005)
Technical Production Scientist @ (September 2001 - April 2003)
Research Scientist @ (May 1999 - September 2001)
Mitch Lewandowski Education
University of Minnesota
Master Of Public Health (Epidemiology)
2011
Boston U
Bachelor Of Arts (Biochemistry)
1999
Mitch Lewandowski Skills
Quality Management
Process Review
Consulting
Planning
Screening
Modular
Sales
ISO
System Software
Compound Screening
Change Control
Regulatory Affairs
Oversight
Product Catalog
Protocol
NDA
PMA
Aql
Regulatory Compliance
Cancer
Regulatory Agencies
Categorization
Management
Design
Science
Assurance
Cfr
Integration
Metrics
IVD
Blood
Assembly Language
Reliability
Process Validation
Data Validation
Manufacturing Operations
Engineers
Nyse
Strategy
Acquisitions
Medicine
Testing
Risk Management
Training
Oracle Agile
Market Risk
Operational Excellence
Complexity Theory
Documentation
Project Management
Process Engineering
Nuclear Medicine
Inspection
Life Science
Laboratory
Anvisa
Design Control
Accreditation
Registration
Business Integration
DNA
Life Sciences
Quality Assurance
Strategic Planning
Quality System
Maintenance
Marketing
CMS
Black Belt
TFS
Design Assurance
Technical Production
CLIA
Services
Distribution
Occlusion
Oracle Agile PLM
Reviews
Manufacturing Systems
Commission
Process Improvement
Medical Devices
Software
Product Design
Oracle
Program Management
Manufacturing
Customer Engagement
Scientists
Pharmaceutical Industry
Supply Chain
Mergers and Acquisitions
Biomarkers
FDA
Measurement System Analysis
International Business
ISO 14971
Enterprise Risk Management
Biotechnology
u.s. Food and Drug Administration Fda
Product Life Cycle Management
GLP
Quality Systems
Statistics
21 CFR Part 11
Good Laboratory Practice Glp
GMP
Validation
V&V
GCP
Operational Risk Management
Product Development
CAPA
Verification and Validation V&V
Regulatory Requirements
M&A due diligence
Business Process Improvement
Technology Transfer
ISO 13485
Six Sigma
Corrective and Preventive Action Capa
Product Lifecycle Management
u.s. Food and Drug Administration
Verification and Validation
Corrective and Preventive Action
Good Laboratory Practice
Mitch Lewandowski Summary
Mitch Lewandowski, based in Saint Paul, MN, US, is currently a EVP Quality Assurance at SANUWAVE. Mitch Lewandowski brings experience from previous roles at RapidAI, GRAIL, Inc., PCI Pharma Services and Dohmen Life Science Services. Mitch Lewandowski holds a Master Of Public Health in Epidemiology @ University of Minnesota. With a robust skill set that includes Quality Management, Process Review, Consulting, Planning, Screening and more. Mitch Lewandowski has 3 emails and 5 mobile phone numbers on RocketReach.
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