2024 -2026 VP Regulatory Affairs and Quality Assurance @
2020 -2024 Vice President, Quality @
2017 -2020 Executive Director of Quality @
2015 -2017 Director Quality Assurance @
2012 -2015 Senior Director Quality Assurance @
2011 -2012 Design Assurance Manager @
2007 -2010 Manager, Quality Assurance @
2005 -2007 Senior Project Manager @
2003 -2005 Sr Technical Operations Scientist @
2001 -2003 Technical Production Scientist @
1999 -2001 Research Scientist @
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 1 mobile phone numbers on RocketReach.
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