Senior Director, Quality - Medical Devices,

About the role

At Baxter, every quality decision has the potential to impact patients who depend on life-sustaining medical devices every day. As Senior Director, Quality - Medical Devices, you will lead Quality strategy and performance across Baxter's Infusion Therapies & Platforms (ITP) medical device network, ensuring the safety, quality, compliance, and reliable supply of products used by patients and healthcare providers around the world. The senior Quality leader is responsible for quality strategy, governance, organizational capability, regulatory compliance, and business performance across a global medical device network. Leading a large, geographically dispersed organization, you will provide executive oversight of Design Quality, Manufacturing Quality, and Post-Market Surveillance activities across the full product lifecycle, from development through commercialization and ongoing market performance. Success in this role means strengthening regulatory confidence, enabling reliable supply, advancing operational excellence, driving product and patient safety, and developing a high-performing organization focused on quality excellence.

Responsibilities

• Develop and execute a multi-year Quality strategy that strengthens compliance, product quality, organizational capability, and business performance across Baxter's medical device network.
• Lead Quality governance and decision-making processes that promote consistency, accountability, risk management, and operational excellence across multiple sites and functions.
• Provide executive oversight for Design Quality, Manufacturing Quality, and Post-Market Surveillance activities across the medical device lifecycle.
• Partner with senior leaders across Manufacturing, R&D, Regulatory Affairs, Supply Chain, Finance, HR, and Commercial functions to support innovation, lifecycle management, and reliable product supply.
• Champion regulatory compliance and inspection readiness across global medical device operations while building strong, credible relationships with health authorities, notified bodies, and regulatory agencies.
• Ensure effective integration of Design Quality, Manufacturing Quality, Regulatory Affairs, and Post-Market Surveillance activities to support product lifecycle excellence.
• Lead quality oversight of new product development, design changes, product transfers, sustaining engineering activities, and lifecycle management initiatives.
• Drive enterprise-wide quality transformation, remediation, and continuous improvement initiatives that deliver sustainable business results.
• Make risk-based decisions that balance patient safety, product quality, regulatory requirements, supply continuity, and business objectives.
• Lead and oversee regulatory inspections, audits, and compliance activities across global medical device operations.
• Build, coach, and develop high-performing leaders while strengthening succession planning and organizational capability across the Quality organization.
• Provide executive-level insights, reporting, and recommendations related to quality performance, compliance risks, business priorities, and strategic initiatives.
• Partner with executive leadership to ensure Quality remains a competitive advantage while supporting growth, innovation, and operational excellence across the business.
• Travel up to 40% to manufacturing sites and vendors.

Requirements

• 15+ years of progressive Quality leadership experience within the medical device industry, with a proven track record leading Quality strategy, compliance, governance, and organizational performance across complex manufacturing and product development