Susteren, Limburg, Netherlands
Quality and Regulatory Leader with expertise in aligning compliance and innovation across medical and non-medical technologies, including SaaS, PaaS, IaaS, SaMD, Cloud, Ops, and AI. Passionate about driving quality excellence and regulatory strategy to enable streamlined processes and successful product launches. Currently Director of QMS, CAPA and Continuous Improvement at Philips MRI, with experience across corporate, startup, and non-profit sectors. Proven track record in leading global teams, implementing Quality Management Systems, and ensuring compliance with international standards such as IEC 62304, ISO 13485, ISO 9001, ISO 14971, FDA QSR, and EU MDR. Author of industry guidance documents.
Leading Quality Engineering activities of the Strategy & Innovation (I&S) Cluster (cluster size ~6000 FTEs). Functionally managing the Quality Engineers (~30FTEs) of the I&S Cluster. Responsible for driving standard practices across I&S Quality Engineers, ensuring key initiatives are prioritized and providing a community to foster best practices for I&S Quality Engineers. Accountable for: - oversight of quality and risk management throughout the product lifecycle with focus on the development phase and across the Cluster. - ensuring that risk-based design controls are applied to all products, components and prototypes which are developed in the cluster. - ensuring that all activities are conducted in accordance with applicable standards & regulations to facilitate transfer into (clinical) studies, further development and/or commercialization.
- Content expert and co-author of AAMI TIR45:2023 "Guidance on the use of AGILE practices in the development of medical device software" - co-author of "AAMI CR510:2021 Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices"
• Established the foundational Quality Management System (QMS) for the company, providing a robust framework for ensuring quality and compliance in the development and delivery of In Vitro Diagnostic (IVD) devices and other medical and non-medical products. • Successfully led the planning and execution of the overall quality and regulatory strategy for the IVD device and other products, ensuring adherence to applicable regulatory requirements, industry standards, and best practices
• Led end-to-end software development efforts, including client/server, embedded, smartphone/desktop apps, and databases, for several innovative products in diverse fields such as medical, connected care, IoT, digital health, wellness, sport, and automotive. • Successfully delivered software solutions for a range of products, including a real-time photonic cancer detector, a platelet/thrombocyte automated counter (IVD), a contactless sleep sensor for medical applications, an activity monitor for wheelchair users, a Parkinson posture correction & cueing device, and an inclination sensor to track aerodynamic cycling posture.