Senior Quality Leader - Regulatory Excellence & CI

Baxter International Inc.; Monterrey; On-site; MXN 900,000 - 1,600,000; Full time

Job summary

Baxter International Inc. is seeking a Senior Quality Manager to provide strategic and operational leadership for the Quality organization at our Monterrey site.

The role focuses on patient safety, regulatory compliance, and continuous improvement, serving as a key member of the site QA leadership team and a Site QA Head designee. You will drive quality escalations, manage post-market quality processes, and lead cross-functional teams to strengthen the QMS and ensure alignment with FDA/ISO

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or related technical discipline (Master’s preferred).
• 7+ years of experience in Quality Assurance/Quality Engineering in a regulated industry (medical device preferred).
• 3+ years in leadership or supervisory roles within QA/QC functions.
• Strong working knowledge of FDA 21 CFR Part 820/11 and ISO 13485 requirements.

Responsibilities

• Define and execute the site Quality strategy, ensuring alignment with business objectives, regulatory requirements, and global quality standards.
• Ensure effectiveness, compliance, and continuous improvement of the Quality Management System (QMS) across all processes.
• Drive internal and external quality escalations, ensuring rapid containment, structured problem-solving, and effective communication with stakeholders, including leadership, customers, and regulatory bodies.
• Utilize data trending and signal detection to proactively identify risks and drive systemic improvements.
• Strengthening systems and processes to ensure audit readiness and sustained regulatory compliance.
• Lead, mentor, and develop the Quality organization, fostering a culture of quality ownership, accountability, and continuous improvement.
• Strengthen team capability in problem-solving, compliance, and quality systems execution.
• Promote a culture aligned with patient safety, regulatory excellence, and ethical standards.

Skills

Quality leadership

Regulatory understanding

Problem solving

Stakeholder communication

Education

Bachelor’s degree in engineering or Life Sciences

Master’s degree preferred

Job description

Baxter International Inc. is seeking a Senior Quality Manager to provide strategic and operational leadership for the Quality organization at our Monterrey site.

The role focuses on patient safety, regulatory compliance, and continuous improvement, serving as a key member of the site QA leadership team and a Site QA Head designee. You will drive quality escalations, manage post-market quality processes, and lead cross-functional teams to strengthen the QMS and ensure alignment with FDA/ISO