Senior Director of Regulatory Compliance @ (March 2014 - October 2015)
Senior Notified Body Project Manager @ DEKRA Certification (formerly KEMA Medical) (March 2005 - March 2014)
Director, Research and Development @ Oculus Innovative Sciences (March 2004 - March 2005)
Manager, IVUS Disposable Development; Senior Scientist, IVUS Transducer Development @ Jomed Inc./Volcano Therapeutics, CA, USA & Jomed Imaging Limited, UK (June 2000 - March 2004)
Doctoral Research Associate @ Laboratoire d'Aérothermique (CNRS) (November 1999 - March 2000)
PhD Student @ UKAEA, Culham (January 1995 - January 1999)
Keith Morel Education
Imperial College London
PhD (Plasma Physics (Nuclear Fusion))
1995-1999
Imperial College London
BSc (Physics)
1992-1995
UCSF Extension
Keith Morel Skills
ISO 13485
Medical Devices
Quality Systems
Design Control
R&D
Risk Management
Design Dossiers
Combination Devices (drug-device combinations)
Statistical Data Analysis
Clinical Evaluation for Medical Devices
Medical Device Directive
Quality System
ISO 14971
Product Development
ISO
Process Simulation
Testing
Biomedical Engineering
21 CFR Part 11
Quality Auditing
CE marking
V&V
CAPA
Manufacturing
Quality Management
Validation
Design of Experiments
Regulatory Affairs
Regulatory Submissions
GMP
Quality Assurance
Quality Control
FMEA
DMAIC
Cardiovascular Devices
Verification and Validation (V&V)
ISO Standards
Corrective and Preventive Action (CAPA)
Research and Development (R&D)
Verification and Validation V&V
Corrective and Preventive Action Capa
Research and Development R&d
Combination Devices Drug Device Combinations
Verification and Validation
Corrective and Preventive Action
Research and Development
Combination Devices
Keith Morel Summary
Keith Morel, based in Los Angeles, CA, US, is currently a VP of Regulatory Compliance and Medical Device Business Unit Lead at Qserve Group US Inc.. Keith Morel brings experience from previous roles at USC School of Pharmacy and Accuray. Keith Morel holds a 1995 - 1999 PhD in Plasma Physics (Nuclear Fusion) @ Imperial College London. With a robust skill set that includes ISO 13485, Medical Devices, Quality Systems, Design Control, R&D and more. Keith Morel has 5 emails and 4 mobile phone numbers on RocketReach.
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