Senior Quality Leader: Regulatory & Patient Safety

Baxter International; Monterrey; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

Baxter International Inc. is seeking a Senior Quality Manager for our Monterrey site. You will lead the Quality organization, partner with regulatory and cross-functional teams, and drive continuous improvement across the product lifecycle to ensure patient safety and compliance.

The role requires a strong background in QA/QC within regulated environments (medical devices preferred), and a track record of building capable teams, improving QMS processes, and guiding risk-based decision making.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or a 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 objectives, regulatory requirements, and global standards.
• Ensure effectiveness, compliance, and continuous improvement of the QMS across processes.
• Lead internal and external quality escalations, containment, and effective communication with stakeholders.
• Utilize data trending to proactively identify risks and drive systemic improvements.
• Strengthen systems to ensure audit readiness and sustained regulatory compliance.
• Lead, mentor, and develop the QA organization with a culture of ownership.
• Promote a culture aligned with patient safety and regulatory excellence.

Skills

Quality leadership

Regulatory knowledge

Risk management

Cross-functional collaboration

Data-driven decision making

Education

Bachelor's degree in engineering/Life Sciences

Master’s degree preferred

Job description

Baxter International Inc. is seeking a Senior Quality Manager for our Monterrey site. You will lead the Quality organization, partner with regulatory and cross-functional teams, and drive continuous improvement across the product lifecycle to ensure patient safety and compliance.

The role requires a strong background in QA/QC within regulated environments (medical devices preferred), and a track record of building capable teams, improving QMS processes, and guiding risk-based decision making.