Resumes
Resumes
Director, Quality Compliance At Edwards Lifesciences
View pageLocation:
San Diego, CA
Industry:
Medical Devices
Work:
TUV America since Jan 2009
Division Manager Active Medical Devices
TUV America Sep 2004 - Dec 2008
Medical Lead Auditor / Project Manager
Division Manager Active Medical Devices
TUV America Sep 2004 - Dec 2008
Medical Lead Auditor / Project Manager
Education:
Technische Universität Dresden 1991 - 1997
Master, Biomedical Engineering
Master, Biomedical Engineering
Skills:
Iso 13485
Medical Devices
Iso 14971
Quality Auditing
Quality System
Fda
Capa
Gmp
Quality Management
Medical Device Directive
Design Control
Testing
Quality Assurance
Iso 9000
Validation
Regulatory Affairs
V&V
Iso
R&D
Quality Control
Product Development
Biomedical Engineering
Iec 60601
Change Control
Business Process Improvement
U.s. Food and Drug Administration
Iso Standards
Iso 14001
International Business
Global Operations
Operations Management
Verification and Validation
Medical Devices
Iso 14971
Quality Auditing
Quality System
Fda
Capa
Gmp
Quality Management
Medical Device Directive
Design Control
Testing
Quality Assurance
Iso 9000
Validation
Regulatory Affairs
V&V
Iso
R&D
Quality Control
Product Development
Biomedical Engineering
Iec 60601
Change Control
Business Process Improvement
U.s. Food and Drug Administration
Iso Standards
Iso 14001
International Business
Global Operations
Operations Management
Verification and Validation
Languages:
English
German
French
German
French