David Rowe
About David Rowe
David Rowe serves as the Senior Quality and Compliance Manager at Hinge Health, where he has worked since 2021. He manages global supplier quality teams and oversees quality and cost management, ensuring alignment with the company's quality management system.
Work at Hinge Health
David Rowe has served as the Sr. Quality and Compliance Manager at Hinge Health since 2021. In this role, he manages global supplier quality teams, contract manufacturers, and material vendors, ensuring they align with Hinge Health's quality management system. He oversees field quality and cost management for the Quality team, focusing on driving organizational efficiencies in operations. Rowe is responsible for defining and executing end-to-end reliability tests for Hinge Health hardware products, maintaining high standards of product quality and reliability. He also implemented the company's first Quality Management System (QMS) and Product Lifecycle Management (PLM) system in accordance with CFR 820 guidelines.
Previous Experience at Molekule
Before joining Hinge Health, David Rowe worked at Molekule from 2018 to 2021. He held the position of Manager - Quality, Reliability & Compliance for three years, where he was responsible for overseeing quality assurance processes. Prior to this role, he served as a Quality Engineer at Molekule for ten months in 2018. His experience at Molekule contributed to his expertise in quality management and compliance within the technology and health sectors.
Background in Bioengineering
David Rowe studied at the University of California, Merced, where he earned a Bachelor of Science (B.S.) degree in Bioengineering and Biomedical Engineering from 2009 to 2014. This educational background provided him with a strong foundation in engineering principles and practices, which he has applied throughout his career in quality and compliance management.
Experience at Pure Storage
Rowe worked at Pure Storage from 2015 to 2018 as a Manufacturing/Product Quality Engineer. In this role, he focused on ensuring product quality throughout the manufacturing process. His experience at Pure Storage further developed his skills in quality assurance and compliance, which he later applied in his roles at Molekule and Hinge Health.
Regulatory Compliance Achievements
At Hinge Health, David Rowe led the organization through its first FDA audit, achieving zero 483 observations, which is a notable accomplishment in regulatory compliance. He plays a key role in supporting product regulatory compliance activities, ensuring that products maintain compliance during their sustaining phases. His expertise in defining and executing manufacturing process requirements, including the development and review of pFMEAs and standard operating procedures, underscores his commitment to quality management.