For over 25 years I have worked at increasing levels of responsibility within the Quality Assurance function at various medical and combination device companies. My executive leadership experience, knowledge, & diversity has served to improve both processes and systems. I have effectively led Quality Teams at multiple design & manufacturing sites responsible for the overall health and compliance of the Quality Management System. I have been accountable for sustaining an effective Quality Management System that delivers safe and reliable products and services to my organization’s customers. My experience and results with regulatory and health authority inspections have been successful by establishing a robust Quality System and always operating in a consistent state of compliance with Medical Device Regulations and International standards. As an experienced executive professional in the medical device industry, the following key strengths establish my strategic leadership capabilities to manage and guide teams towards achieving excellence in quality systems, engineering, manufacturing, supply chain, and new product development. My risk-based methodology and practical decision-making has been effective in navigating and resolving complex challenges with a keen focus on mitigating potential pitfalls.• Strategic Quality Leadership & Planning• Risk-Based Decision Making• CapEx & OpEx Budget Deployment• Team Development & Empowerment• Facilitator & cross-functional collaborator• Product Design and Process Validation• Design for Manufacturability• CI Tools (5S, GEMBA, Lean, 6σ, VSM)• eQMS & PLM System Implementations• Mergers, Acquisitions, & Integrations