Head of Quality, Ambulatory Monitoring & Diagnostics

Job Title Head of Quality, Ambulatory Monitoring & Diagnostics Job Description Head of Quality, Ambulatory Monitoring & Diagnostics The Head of Quality, Ambulatory Monitoring & Diagnostics (AM&D), is a key leadership role responsible for defining and leading the quality vision and strategy across the AM&D business, teams, and associated sites. This leader serves as a driving force in positioning AM&D as an industry-leading organization by advancing customer experience, proactive quality excellence, and sustained regulatory compliance across FDA-regulated medical devices, EU MDR, and other applicable global regulatory requirements and competent authorities. The role provides strategic direction and leadership to quality leaders across the organization, identifies and drives opportunities for continuous improvement and innovation in quality processes, and ensures a strong culture of quality is embedded throughout the business. Through proactive leadership, collaboration, and a commitment to quality excellence, the Head of Quality enables AM&D to consistently meet regulatory expectations, strengthen organizational performance, and deliver high-quality products and experiences to customers.

Lead the global Quality strategy for the AM&D business, ensuring product safety, regulatory compliance, operational excellence, and alignment with business growth objectives. Define and execute a forward-looking global Quality strategy across products, software, services, sites, and operations. Ensure compliance and inspection readiness across global regulations and standards, including FDA, EU MDR, ISO 13485, 21 CFR 820, and other international requirements. Serve as Management Representative and primary interface with global regulatory authorities, including FDA, EU authorities, TGA, MHLW, and NMPA. Provide strategic oversight of the Quality Management System, regulatory submissions, post-market surveillance, product safety, and lifecycle compliance. Lead and develop a global team of quality professionals, establishing common goals that improve product quality, customer experience, compliance, and operational performance. Partner with business, site, market, functional, and central leadership teams to drive strategic initiatives, transformation, standardization, and continuous improvement. Act as a key member and change agent within the cross-functional business leadership team, influencing quality, compliance, and business outcomes. Drive an effective and efficient QMS, standardized process execution, best-practice adoption, and continuous improvement. Lead organizational planning, talent and succession management, staffing, budgeting, performance management, and capability development for the Quality function. You're the right fit if: Bachelor's degree (Science, Engineering or similar technical discipline) required, Master's degree in business, management or quality strongly preferred Minimum 15 years global MedTech industry with demonstrating progressive leadership Strong leadership skills and the ability to function well within a matrix organization Leadership experience in various aspects of Quality, such as design quality, quality systems, post market surveillance and internal / external audit representation Experience in leading a team in establishing and implementing Quality strategy, Quality systems, etc for multi-site business in a large multi-national company Relevant training, experience, and certification in Continuous Improvement practices such as Lean/Six Sigma (highly preferred). Must be comfortable working with abstract ideas or situations across functional areas of the business on a regular basis Must be a strategic thinker, who through the assessment of intangible variables, can readily identify, evaluate the fundamental issues, and provide strategy and direction to enable a successful outcome. Must bring a quality first mentality and drive a high quality, customer driven culture within a large global