I am Mark Swanson; a freelance consultant advising companies in quality management systems and business practices. Specifically, I advise quality managers and other senior management in meeting industry standards and regulations for medical devices as well as general ISO management requirements.
Prior to this, I was at Medtronic for more than 11 years in various quality roles. My responsibilities grew over the years to include a very wide breadth of skills in design quality, operational quality, post-market product assurance, and regulatory submissions. I have experience with all classes of medical devices including heart valves, life support in cardiac bypass, cell salvage, in vitro diagnostics and combination devices. In addition, I have a strong understanding of project management and problem solving gained though several continuous improvement projects where I have used lean and six sigma concepts to drive results.
My work is aimed at coaching senior management in establishing quality management systems and strategic direction to thrive in regulated environments.