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Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of King & Spalding. Eric is a 30-year industry veteran having led and coached global organizations through a wide variety of quality and compliance challenges. Complementing his leadership experience is an extensive hands-on skillset including audit management and response, organizational change management, Quality System remediation, software quality (including cybersecurity and AI/ML), medical device design controls, risk management, and regulatory due diligence.
Eric came to King & Spalding from Philips, where he was the Global Head of the Quality Assurance / Quality Engineering organization for the Diagnostic Imaging Business Group, which included seven business units spanning 14 sites globally. Prior to Philips, Eric led design quality assurance at Medtronic’s Diabetes Business Unit, was responsible for software design controls and general design controls effectiveness for GE Healthcare for all GE businesses worldwide, and had software quality and software design leadership responsibility at Boston Scientific and Hologic.
Eric has hands-on problem-solving and organizational change management experience, as it relates to large process improvement initiatives, the defense of quality systems to third parties (e.g. FDA, notified bodies, CFDA), quality system remediation programs (including under FDA enforcement actions), and the execution of product development programs, where both quality and global compliance are mission critical.
Prior to entering the medical device industry, Eric led a software quality management and program management office consulting capability in the Washington, DC area and held software design and development leadership roles in a small startup, a mid-size healthcare software company, a large financial services regulator and stock market, and a large retail organization.
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