Global Quality Director, Medical Devices & Strategy

Baxter International Inc.; Round Lake (IL); On-site; USD 216,000 - 297,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with company matching

Paid time off (20–35 days)

Employee Stock Purchase Plan (ESPP)

Job summary

Baxter International Inc. is seeking a Senior Director, Quality - Medical Devices to lead strategy and governance for quality across a global medical device network.

You will oversee Design Quality, Manufacturing Quality, and Post-Market Surveillance, partnering with executive leaders to drive lifecycle excellence and regulatory readiness. The role requires 15+ years in quality leadership within medical devices, a engineering/science degree (advanced degree preferred), and a track record of

Qualifications

• 15+ years of progressive quality leadership experience in the medical device industry.
• Bachelor's degree in Engineering, Science, or related discipline required; advanced degree preferred.
• Deep expertise in medical device quality systems, regulatory requirements, inspection management, and risk mitigation.
• Proven ability to lead Design Quality, Manufacturing Quality, and Post-Market Surveillance organizations within a regulated medical device environment.

Responsibilities

• Develop and execute a multi-year Quality strategy across Baxter's medical device network.
• Lead Quality governance and decision-making across multiple sites and functions.
• Provide executive oversight for Design Quality, Manufacturing Quality, and Post-Market Surveillance activities across the lifecycle.
• Partner with senior leaders across Manufacturing, R&D, Regulatory Affairs, Supply Chain, Finance, HR, and Commercial to support lifecycle management and reliable product supply.
• Champion regulatory compliance and inspection readiness globally.
• Ensure integration of Design Quality, Manufacturing Quality, Regulatory Affairs, and Post-Market Surveillance across lifecycle.
• Lead quality oversight of new product development, design changes, product transfers, sustaining engineering, and lifecycle initiatives.
• Drive enterprise-wide quality transformation and continuous improvement initiatives.
• Make risk-based decisions balancing patient safety, regulatory requirements, and supply continuity.
• Lead regulatory inspections, audits, and compliance activities globally.
• Develop leaders and strengthen succession planning within Quality.
• Provide executive insights and recommendations on quality performance and strategic initiatives.
• Partner with leadership to keep Quality a competitive advantage.
• Travel up to 40% to manufacturing sites and vendors.

Skills

Quality leadership

Regulatory compliance

Executive communication

Cross-functional leadership

Budget management

Education

Bachelor's degree in Engineering/Science

Advanced degree preferred

Job description

Baxter International Inc. is seeking a Senior Director, Quality - Medical Devices to lead strategy and governance for quality across a global medical device network.

You will oversee Design Quality, Manufacturing Quality, and Post-Market Surveillance, partnering with executive leaders to drive lifecycle excellence and regulatory readiness. The role requires 15+ years in quality leadership within medical devices, a engineering/science degree (advanced degree preferred), and a track record of