Andy Mathein
Vice President, Quality and Regulatory Affairs
- Role
- Vice President, Quality & Regulatory Affairs at ICU Medical
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
Manufacturing & ProductionView LinkedIn profile
Experience
Vice President, Quality & Regulatory Affairs
Mar 2022 — Present
Quality Shared Services and Business Unit QA Support (Tracheostomy, Respiratory & Anesthesia)
Skills
- Cross-Functional Team Leadership
- Supplier Quality
- Iso 14971
- Corrective and Preventive Action (Capa)
- U.s. Food and Drug Administration (Fda)
- Validation
- Design Control
- Quality Engineering
- Continuous Improvement
- Quality System
- Quality Systems
- V&V
- Medical Device Product Development
- Fmea
- Design of Experiments
- Fda
- Quality Auditing
- Iso 13485
- Failure Mode and Effects Analysis (Fmea)
- Medical Devices
- Capa
- Quality Control
- Gmp
- Auditing
- 510 K
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