Senior Quality Manager (Medical Devices)

Location: Monterrey, Nuevo León, Mexico

Company

Healthcare organization focused on improving healthcare delivery and developing solutions that help save and sustain lives.

What you will do

• Define and execute the site Quality strategy in alignment with business objectives, regulatory requirements, and global quality standards.
• Maintain the effectiveness, compliance, and continuous improvement of the Quality Management System across site processes.
• Lead internal and external quality escalations, including containment, structured problem-solving, and stakeholder communication.
• Use data trending and signal detection to identify risks and drive systemic improvements across the product lifecycle.
• Strengthen audit readiness, regulatory compliance, and quality systems execution.
• Lead, mentor, and develop the Quality organization while promoting patient safety, accountability, and ethical standards.

Requirements

• Bachelor’s degree in engineering, Life Sciences, or a related technical discipline; a master’s degree is preferred.
• At least 7 years of Quality Assurance or Quality Engineering experience in a regulated industry, preferably medical devices.
• At least 3 years of leadership or supervisory experience in QA/QC functions.
• Strong working knowledge of FDA 21 CFR Part 820/11 and ISO 13485 requirements.
• On-site work in Monterrey, Nuevo León, Mexico.

Culture & Benefits

• Mission-driven work focused on patient safety and saving and sustaining lives.
• Culture centered on courage, trust, collaboration, ownership, and accountability.
• Commitment to continuous improvement, regulatory excellence, and ethical standards.
• Equal employment opportunity and reasonable accommodations for candidates with disabilities.