Senior Director, Quality - Medical Devices

Baxter • Round Lake, IL

4d • Hybrid

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter 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.

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 environments.
• Bachelor's degree in Engineering, Science, or a related discipline required; advanced degree preferred.
• Deep expertise in medical device quality systems, regulatory requirements, inspection management, and risk mitigation.
• Demonstrated success leading Design Quality, Manufacturing Quality, and Post-Market Surveillance organizations within a regulated medical device environment.
• Strong knowledge of global medical device regulations and standards, including FDA Quality System Regulation / Quality Management System Regulation (QSR/QMSR), ISO 13485, EU MDR, MDSAP, and related requirements.
• Proven ability to influence executive stakeholders and guide high-impact business decisions.
• Demonstrated success leading quality transformation, remediation, and continuous improvement initiatives across multiple sites and functions.
• Experience leading large, geographically dispersed teams through organizational growth, change, and business transformation.
• Strong business acumen with experience managing significant budgets, investments, and strategic operating plans.
• A collaborative leadership style with a passion for developing talent, building inclusive teams, and fostering a culture of accountability and continuous improvement.
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

• advanced degree preferred

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.

Benefits

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior