Senior Quality Leader: Regulatory & Continuous Improvement

Baxter International Inc.; Monterrey; On-site; MXN 1,200,000 - 2,000,000; Full time

Job summary

Baxter International Inc. in Monterrey, Mexico, seeks a Senior Quality Manager who will lead the Quality organization with a focus on patient safety, regulatory compliance, and continuous improvement within a regulated medical device environment.

You will consolidate the QMS, guide risk management, manage escalations, and drive data-driven improvements across the product lifecycle, partnering with cross-functional teams to ensure audit readiness and regulatory alignment.

Qualifications

• Bachelor’s degree in engineering or life sciences; Master’s preferred.
• 7+ years in Quality Assurance/Quality Engineering in a regulated industry (medical devices preferred).
• 3+ years in leadership or supervisory roles within QA/QC.

Responsibilities

• Define and execute the site Quality strategy aligned with regulatory standards.
• Ensure effectiveness and continuous improvement of the QMS across processes.
• Lead internal and external quality escalations with rapid containment and clear communication.
• Use data trending to identify risks and drive systemic improvements.
• Strengthen audit readiness and regulatory compliance programs.
• Lead and develop the Quality organization fostering ownership and accountability.
• Strengthen team capability in problem-solving and quality systems execution.
• Promote a culture of patient safety and regulatory excellence.

Skills

Quality Assurance

Leadership

Regulatory compliance

Risk management

Data-driven decision making

Education

Bachelor’s degree in engineering or Life Sciences

Master’s degree preferred

Job description

Baxter International Inc. in Monterrey, Mexico, seeks a Senior Quality Manager who will lead the Quality organization with a focus on patient safety, regulatory compliance, and continuous improvement within a regulated medical device environment.

You will consolidate the QMS, guide risk management, manage escalations, and drive data-driven improvements across the product lifecycle, partnering with cross-functional teams to ensure audit readiness and regulatory alignment.