Steven Allison

Background

About Steven Allison

As a Sr. Vice President of Quality and Regulatory, I am responsible for all global quality and regulatory activities for the company's operations, including manufacturing, design, and distribution of class I and II durable medical equipment and respiratory products. With over 20 years of experience in the field, I am a transformational leader, strategic thinker, skilled communicator, team builder, and adept negotiator who blends expertise in global regulatory affairs and quality management with exceptional skills in business development and operations management.My core competencies include FDA (QSR) Quality Systems, ISO 13485/ISO 14971 Risk Management, and Strategic Programs. I have successfully led the implementation of a global Quality Improvement Program (QIP) that addressed the core elements of the QMS, such as CAPA, Complaint Handling/Trending, Training, Medical Device Reporting (MDR), Design Controls, and Design Transfer. I have also spearheaded the update of the QMS and Technical Files to comply with the IVDR requirements, and established collaborative working relationships with manufacturing, R&D, and various business partners. My mission is to position quality as a competitive business advantage, while ensuring regulatory compliance and product quality. I am passionate about driving cultural transformation and change management, and empowering my global team of over 400 quality professionals.