Global VP, Quality Assurance - Medical Devices

Baxter International Inc.; Deerfield (IL); On-site; USD 280,000 - 410,000; Full time

Benefits offered by this job

Health and life insurance

401(k) with matching

Paid time off 20–35 days

Job summary

Baxter International Inc. is seeking a Vice President, Global Quality Assurance for MDS to set global quality strategy and lead quality across three medical device businesses.

You will guide risk-based decisions, collaborate with regulators, and drive a high-performing quality organization globally. The role requires extensive regulatory expertise, executive leadership experience in a highly regulated industry, and the ability to influence senior stakeholders.

Qualifications

• At least 15 years of experience in Quality, Engineering, Manufacturing, or a related function within a highly regulated industry.
• 10+ years in progressively senior Quality or Operations leadership roles.
• Executive-level experience leading large, global matrixed Quality organizations with accountability for quality systems, regulatory compliance, operational performance, and organizational capability.
• Deep medical device expertise spanning product development, design transfer, manufacturing, distribution, post-market activities, and product lifecycle management.
• Advanced knowledge of global medical device quality and regulatory requirements, including FDA QSR, EU MDR, ISO 13485, and ISO 14971.
• Demonstrated ability to make timely, well-informed decisions when product quality, patient safety, regulatory compliance, or supply may be at risk, with strong communication to influence senior leaders and regulators.

Responsibilities

• Set the global MDS Quality strategy, priorities, governance, and operating model in alignment with Baxter’s quality vision and business objectives.
• Lead quality across three medical device businesses, strengthening accountability and consistency while addressing the distinct needs of each product portfolio, technology, manufacturing network, and regulatory pathway.
• Advance scalable Quality Management Systems that improve compliance, simplify ways of working, support innovation, and promote continuous improvement throughout the product lifecycle.
• Guide manufacturing, design, product, supplier, and external manufacturing quality to support inspection readiness, effective product controls, supply continuity, and reliable delivery of compliant products.
• Direct risk-based decisions and escalation strategies when product quality, regulatory compliance, supply, or patient safety may be affected, including recommendations related to potential field actions.
• Partner with global regulatory authorities, notified bodies, business leaders, and cross-functional teams to support inspections, address quality concerns, and deliver sustainable remediation.
• Build a diverse, capable, and connected global Quality organization through leadership development, succession planning, clear accountability, and an environment where people can contribute and grow.
• Estimated expected domestic and international travel up to 30-50%.

Skills

Executive leadership

Regulatory knowledge

Decision making

Communication

Education

Master's degree

Job description

Baxter International Inc. is seeking a Vice President, Global Quality Assurance for MDS to set global quality strategy and lead quality across three medical device businesses.

You will guide risk-based decisions, collaborate with regulators, and drive a high-performing quality organization globally. The role requires extensive regulatory expertise, executive leadership experience in a highly regulated industry, and the ability to influence senior stakeholders.