Associate Director Quality @ (September 2022 - February 2025)
Quality and Regulatory Affairs Manager @ (June 2017 - September 2022)
Quality and Regulatory Manager @ (December 2011 - June 2017)
Manager QA and Software Process Improvement @ (October 2000 - December 2011)
Senior Software Engineer @ (February 1998 - September 2000)
Software Engineer @ EDS (contracted by Shell) (February 1993 - February 1998)
PhD Student @ (September 1988 - February 1993)
Dave Bierhuizen Education
Delft University of Technology
Doctor of Philosophy (PhD) (Electrical Engineering)
1988-1993
Dave Bierhuizen Skills
Quality Assurance
ISO 13485
FDA
Medical Devices
Software Development
CMM
CMMI
Quality Systems
Quality Management
QSR
GMP
Continuous Improvement
Agile
Six Sigma
Process Improvement
Regulatory Affairs
C++
Java
Web Design
Object Oriented Design
Software Quality Assurance
Metrics
Process Development
CAPA
Quality Engineering
Auditing
510 K
21 CFR Part 11
ISO 14971
Compliance
Agile Methodologies
Image Processing
Quality System
Scrum
Agile Project Management
Software Engineering
Quality Control
Test Management
R&D
Design Control
Medical Imaging
Validation
DICOM
Testing
Strategic Planning
Microsoft Excel
Management
Project Management
Dave Bierhuizen Summary
Dave Bierhuizen, based in The Hague, ZH, NL, is currently a Quality Assurance Manager at Topcon Healthcare Europe. Dave Bierhuizen brings experience from previous roles at Zimmer Biomet, Zimmer Biomet EMEA, Philips and Medis medical imaging systems. Dave Bierhuizen holds a 1988 - 1993 Doctor of Philosophy (PhD) in Electrical Engineering @ Delft University of Technology. With a robust skill set that includes Quality Assurance, ISO 13485, FDA, Medical Devices, Software Development and more. Dave Bierhuizen has 4 emails and 3 mobile phone numbers on RocketReach.
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