Elekta Aug 2006 - Dec 2012
Vice President Quality Assurance and Regulatory Affairs
Elekta Aug 2006 - Dec 2012
Vice President Global Quality Assurance, Regulatory Affairs Governance
Dornier Medtech Jan 2002 - Aug 2006
Qa and Ra Manager
Facet Technologies Llc 1996 - 2002
Qa and Ra Manager
Education:
Southern Polytechnic State University 1987 - 1991
Bachelors, Industrial Engineering
Skills:
Quality Assurance Iso 13485 Medical Device Directive Ce Marking Fda Regulatory Affairs Design Control European Union Corrective Actions Process Improvement Regulatory Submissions Global Regulatory Compliance Regulatory Analysis Iso 14971 Capa Medical Devices Project Management Cross Functional Team Leadership Due Diligence Integration Standards Compliance Compliance Management Validation Quality System Product Development Gmp Quality Auditing Quality Management Manufacturing Iso Healthcare Iso Standards U.s. Food and Drug Administration Corrective and Preventive Action Business Process Improvement Government Liaison Fda Gmp Strategic Leadership Cultural Criticism