Sr. Director - Quality Shared Services @ (October 2017 - March 2022)
Director QRA Mgmt. - Design Assurance @ CareFusion/BD/Vyaire (December 2011 - October 2017)
Design Assurance Manager @ (September 2009 - December 2011)
Principal Quality Engineer @ (November 2007 - September 2009)
Senior Staff Quality Engineer @ (October 2006 - November 2007)
Packaging Engineer @ (June 2005 - October 2006)
Associate Engineer @ (August 2004 - June 2005)
Package Engineering Intern @ (May 2004 - August 2004)
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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