For the past two years, Delve has been working assiduously to put Quality Management Systems (QMS) processes in place that will ultimately lead to our ISO 13485 certification.
We’re are excited to take the next big step in that journey with the addition of Katie Mason as a Senior Quality Engineer. Katie has spent more than 13 years working at Intertek Testing Services in various safety and quality engineering roles. Her experience includes International Compliance with a focus on Medical Devices (60601) and Laboratory Equipment (61010) including Risk Management (ISO 14971), Usability (62366), Software (62304), and QMS used for FDA, and EU MDD/MDR, and GMP.
Katie also has over 10 years of experience managing the Quality System of an ISO 17025, OSHA NRTL, and CB Scheme accredited safety testing laboratory and as Lead Auditor of other such laboratories. She has found that Compliance, Quality requirements, and Risk should be considered (when possible) at the earliest conception during product design to ensure a seamless transition to market.
“Katie is client-focused and has exceptional knowledge of conformity assessment, quality assurance, and project management,” said Kent Kallsen, Vice President of Engineering and Principal, who leads Delve’s ISO certification process. “The addition of her skills and experience will help our teams provide the highest level of service to our medical device clients.”
Katie has a Bachelor of Science in Biological Engineering from Ohio State University. Learn more about Katie.