Tom Dunigan
FDA QSMR/Certified 13485 Lead Auditor, former director of operations and director of quality
- Role
- Senior Representative, Quality Assurance at Novo Nordisk
- Location
- Bloomington, US
- LinkedIn followers
- 500 followers
About Tom Dunigan
In my current consultancy role as Quality Compliance Manager with an IVD business…
Experience
Senior Representative, Quality Assurance
Aug 2025 — Present · Bloomington, IN, US
Education
Indiana University
Bachelor of Science, Microbiology, General
Indiana University Bloomington
Bachelor's degree, Microbiology and Immunology
1981 — 1985
Skills
- Design Control
- Validation
- Strategic Planning
- Lean Manufacturing
- Corrective and Preventive Action (Capa)
- Iso 13485
- Operations Management
- Iso
- Business Process Improvement
- Sop
- Fda
- Team Building
- Management
- Cross-Functional Team Leadership
- Quality Assurance
- Quality Auditing
- Training
- Process Validation
- Quality Control
- Gmp
- Continuous Improvement
- Compliance
- Fmea
- Qsr
- Failure Mode and Effects Analysis (Fmea)
- Process Improvement
- Change Management
- Manufacturing Engineering
- Quality System
- Quality Systems
- V&V
- Process Simulation
- Leadership
- Human Resources
- U.s. Food and Drug Administration (Fda)
- Manufacturing
- Quality Management
- Budgeting
- Project Management
- Software Documentation
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