Senior Quality Leader: Medical Devices, Regulatory & Risk

Zvh; Monterrey; Presencial; MXN 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Baxter is seeking a Senior Quality Manager to provide strategic and operational leadership for the Quality organization. The role focuses on patient safety, regulatory compliance, and continuous improvement across the product lifecycle.

You will lead the QA team, manage quality escalations, and strengthen the QMS while ensuring alignment with global standards and regulatory bodies. This is a senior site leadership position.

Formación

• Bachelor’s degree in engineering or life sciences; 7+ years in QA/QE within a regulated industry.
• 3+ years in leadership or supervisory QA/QC roles.
• Strong knowledge of FDA 21 CFR Part 820/11 and ISO 13485 requirements.

Responsabilidades

• Define and execute the site Quality strategy aligned with regulatory requirements and global standards.
• Drive internal and external quality escalations and ensure audit readiness.
• Lead, mentor, and develop the QA organization with a culture of quality ownership.

Conocimientos

Quality Leadership

Regulatory Compliance

Risk Management

Cross-functional Collaboration

Data-driven Improvement

Educación

Bachelor’s degree in engineering or life sciences

Master’s degree preferred

Herramientas

QMS

Descripción del empleo

Baxter is seeking a Senior Quality Manager to provide strategic and operational leadership for the Quality organization. The role focuses on patient safety, regulatory compliance, and continuous improvement across the product lifecycle.

You will lead the QA team, manage quality escalations, and strengthen the QMS while ensuring alignment with global standards and regulatory bodies. This is a senior site leadership position.