1994 -
2000 President @ Oak Grove Technologies Inc./ Quintiles
1980 -
1993 Engineering Mgr @
Mitchell Januszewski Education
University of Illinois Urbana-Champaign
(Engineering)
1973
-
1977
University of Wisconsin
BSME (Mechanical Engineering)
Mitchell Januszewski Skills
Medical Equipment
Medical Devices
FDA
CAPA
Design Control
ISO 13485
Quality System
V&V
Validation
GMP
Pharmaceutical Industry
Regulatory Affairs
21 CFR Part 11
Biotechnology
Change Control
R&D
Sop
Regulatory Submissions
FMEA
Computer System Validation
Pharmaceutics
Regulatory Requirements
Program Management
ISO 14971
Lifesciences
Six Sigma
Quality Assurance
Cross-functional Team Leadership
Quality Auditing
Biopharmaceuticals
GLP
Quality Control
Technology Transfer
FDA GMP
GxP
Clinical Trials
21 CFR
Quality Management
Commercialization
DMAIC
ISO
Design of Experiments
Manufacturing Operations
Supplier Quality
Biomedical Engineering
Root Cause Analysis
Contract Manufacturing
Aseptic Processing
Cleaning Validation
Clinical Development
Communications
Software Development
Strategic Planning
Compliance
Cross Functional Team Leadership
Business Development
Testing
Computer System
Cross Functional Team
Regulatory Compliance
Sales
Regulatory
Management
Mitchell Januszewski Summary
Mitchell Januszewski, based in Naples, FL, US, is currently a Retired at Retired. Mitchell Januszewski brings experience from previous roles at Regulatory Compliance Associates Inc. (RCA), Oak Grove Technologies Inc./ Quintiles and Baxter Healthcare. Mitchell Januszewski holds a 1973 - 1977 University of Illinois Urbana-Champaign. With a robust skill set that includes Medical Equipment, Medical Devices, FDA, CAPA, Design Control and more. Mitchell Januszewski has 1 emails and 1 mobile phone numbers on RocketReach.
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