Andy Mathein Email & Phone Number
Vice President, Quality and Regulatory Affairs @ ICU Medical
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Andy Mathein Location
- Chicago, IL, US
Andy Mathein Work
- 2022 -now Vice President, Quality and Regulatory Affairs @
- 2017 -2022 Sr. Director - Quality Shared Services @
- 2011 -2017 Director QRA Mgmt. - Design Assurance @ CareFusion/BD/Vyaire
- 2009 -2011 Design Assurance Manager @
- 2007 -2009 Principal Quality Engineer @
- 2006 -2007 Senior Staff Quality Engineer @
- 2005 -2006 Packaging Engineer @
- 2004 -2005 Associate Engineer @
- 2004 -2004 Package Engineering Intern @
Andy Mathein Education
- Michigan State University
Andy Mathein Skills
- FDA
- Supplier Quality
- Validation
- Quality Systems
- FMEA
- CAPA
- Auditing
- Design Control
- ISO 13485
- Quality Engineering
- Medical Device Product Development
- GMP
- 510 K
- Continuous Improvement
- ISO 14971
- Quality Auditing
- Cross-functional Team Leadership
- Quality System
- Medical Devices
- Design of Experiments
- V&V
- Quality Control
- U.S. Food and Drug Administration (FDA)
- Failure Mode and Effects Analysis (FMEA)
- Corrective and Preventive Action (CAPA)
- Leadership
- PowerPoint
- European Union
- Engineering
- Compliance
- Program Management
- Microsoft Excel
- Cross Functional Team Leadership
- Manufacturing
- Design Assurance
- Regulatory Compliance
- Corrective and Preventive Action Capa
- u.s. Food and Drug Administration Fda
- Failure Mode and Effects Analysis Fmea
- u.s. Food and Drug Administration
- Corrective and Preventive Action
- Failure Mode and Effects Analysis
Andy Mathein Summary
- Andy Mathein, based in Chicago, IL, US, is currently a Vice President, Quality and Regulatory Affairs at ICU Medical. Andy Mathein brings experience from previous roles at ICU Medical, CareFusion/BD/Vyaire, CareFusion and Cardinal Health Inc.. Andy Mathein holds a Michigan State University. With a robust skill set that includes FDA, Supplier Quality, Validation, Quality Systems, FMEA and more. Andy Mathein has 1 emails and 2 mobile phone numbers on RocketReach.
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