• Supervise and develop a team of Quality Engineers, coordinating their activities to support company and departmental goals • Build team capability through mentoring, coaching, and fostering technical expertise in regulated medical device development • Manage workload distribution and prioritization across multiple concurrent projects and initiatives • Drive performance management, providing regular feedback and creating development opportunities • Partner with engineering leadership to guide Software, Machine Learning, and Hardware teams through new product development and sustaining engineering • Champion the least burdensome approach to compliance while maintaining regulatory integrity • Drive process improvements across the quality management system to enhance efficiency and effectiveness • Represent Quality in executive-level discussions, audits, and regulatory interactions • Serve as SME for hardware and software compliance processes across design, manufacturing, product release, and post-market support • Lead product release coordination in collaboration with engineering and manufacturing teams • Oversee Software Tool Validation program to meet regulatory and operational requirements • Represent Beacon in second-party (customer) and third-party audits (ISO auditors) and regulatory inspections • Drive MDR compliance and CE marking initiatives for Beacon products • Stay current on international standards and regulations, ensuring organizational awareness • Act as quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control • Ensure timely project delivery on time, within scope, and in compliance with all regulatory requirements