James Madden
Sr. Director of Quality & Regulatory Affairs at Viant Medical
- Role
- Sr Director of Quality & Regulatory Affairs - Aps Division at Viant Medical
- Location
- Aurora, IL, US
- LinkedIn followers
- 500 followers
About James Madden
Accomplished QA professional with 20 years of experience with increasing responsibilities and a proven record of significant and successful contributions in quality management, project management, facility startup, facility shutdown, process improvement, and quality systems management for multiple organizations.Specialties: Technically adept with superb analysis skills engineering, manufacturing processes, validation and medical device practices. Key skills include tech transfers; turnaround situations with domestic and international sites.
Experience
Sr Director of Quality & Regulatory Affairs - Aps Division
Oct 2025 — Present
Education
University of Illinois Urbana-Champaign
Bachelor of Science, Mechanical Engineering
1998 — 2002
Skills
- Medical Devices
- Capa
- International Project Management
- Inspection
- Quality Control
- Gmp
- Quality Auditing
- Quality Management
- Strategic Planning
- Process Engineering
- Program Management
- Cross-Functional Team Leadership
- Supplier Quality
- Iso 14971
- Iso 13485
- Cgmp
- Project Planning
- Quality System
- V&V
- Value Stream Mapping
- Process Improvement
- Validation
- Spc
- Compliance
- Gage R&R
- Fmea
- Qsr
- Calibration
- Problem Solving
- Process Validation
- Quality Assurance
- Product Development
- Ppap
- Risk Analysis
- Software Documentation
- Root Cause Analysis
- Design of Experiments
- Manufacturing
- Iso
- Sop
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