James Madden Email & Phone Number
Sr. Director of Quality and Regulatory Affairs - APS Division @ Viant Medical
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James Madden Location
- Aurora, IL, US
James Madden Work
- 2025 -now Sr. Director of Quality and Regulatory Affairs - APS Division @
- 2018 -2025 Director of Quality and Regulatory Affairs @
- 2013 -2018 Quality Manager @
- 2013 -2013 Principal Quality Engineer @ Accellent
- 2012 -2013 Quality System Program Manager @ Accellent
- 2010 -2012 Asia Quality Systems Program Manager @ Accellent
- 2008 -2010 Quality Engineer @ Accellent
- 2008 -2008 Manufacturing Engineer @
- 2007 -2007 Quality Engineer - Operations @
- 2004 -2007 Process Engineer @
- 2002 -2004 Validation Engineer @ Pharmaceutical Systems Inc
James Madden Education
- University of Illinois at Urbana-Champaign
Bachelor of Science (Bachelor of Science, Mechanical Engineering)
1998-2002
James Madden Skills
- Change Control
- Quality Auditing
- Product Acceptance
- Attention to Detail
- Regulatory Requirements
- Quality Metrics
- Adverse Events
- Management Review
- Internal Audits
- Educational Leadership
- Presentations
- Special Programs
- Succession Planning
- Strategic Initiatives
- Presentation Skills
- Strategic Project Management
- Communication
- Validation
- Medical Devices
- ISO 13485
- CAPA
- SPC
- Lean Manufacturing
- Manufacturing
- FMEA
- Product Development
- Quality Management
- Process Validation
- Root Cause Analysis
- Quality Assurance
- Risk Analysis
- FDA
- Quality Engineering
- MS Project
- Project Planning
- International Project Management
- Engineering
- ISO
- Manufacturing Engineering
- Minitab
- Supplier Quality
- PPAP
- QSR
- Process Improvement
- Problem Solving
- Regulatory Affairs
- Calibration
- Statistics
- cGMP
- Process Engineering
- Compliance
- Inspection
- Program Management
- Strategic Planning
- Quality System
- Cross-functional Team Leadership
- Supplier Quality Management
- Gage R&R
- Sop
- V&V
- GMP
- Software Documentation
- Quality Control
- Design of Experiments
- ISO 14971
- Value Stream Mapping
- SQL
- Cross Functional Team Leadership
- Project Management
- Hospitals
James Madden Summary
- James Madden, based in Aurora, IL, US, is currently a Sr. Director of Quality and Regulatory Affairs - APS Division at Viant Medical. James Madden brings experience from previous roles at Viant Medical, Integer Holdings Corporation and Accellent. James Madden holds a 1998 - 2002 Bachelor of Science in Bachelor of Science, Mechanical Engineering @ University of Illinois at Urbana-Champaign. With a robust skill set that includes Change Control, Quality Auditing, Product Acceptance, Attention to Detail, Regulatory Requirements and more. James Madden has 2 emails and 2 mobile phone numbers on RocketReach.
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