Karen Bell

Karen Bell is a Quality and Regulatory Manager with over 20 years of experience in the medical device industry. She brings specialized expertise in managing quality systems and regulatory compliance within highly controlled environments. Her background also includes work in food production and the transportation of infectious substances—providing a unique, cross-disciplinary perspective that strengthens quality strategies across regulated sectors.

Karen holds a Bachelor of Science in Biochemistry with a minor in Biological Sciences from Simon Fraser University, and a Certificate in Quality Management from the University of Manitoba.

As the Quality Manager at Cube Innovations, Karen ensures strict adherence to Total Quality Management principles, focusing on customer needs, continuous improvement, and cross-functional collaboration. She leverages fact-based decision-making to drive quality and efficiency improvements, ensuring all systems, processes, and products align with Cube’s mission, vision, and values. With extensive knowledge of ISO 13485 standards, regulatory requirements, and process validation, Karen plays a critical role in maintaining compliance within a highly regulated environment.

Her leadership of quality initiatives ensures that Cube’s products not only meet the highest safety and quality standards but also support staff and customers in achieving their goals and improving patient outcomes through controlled and validated processes.