Global QMS Manager - Regulatory Compliance & CAPA

Celestica Inc.; Monterrey; Presencial; MXN 1.200.000 - 2.100.000; Jornada completa

Descripción de la vacante

Celestica Inc. in Monterrey, MX seeks a Global QMS Manager to lead the Quality Management System activities for regulatory harmonization and compliance across sites.

This role trains HT employees, ensures execution of the Quality Plan, and leads CAPA processes with senior leadership interface. Travel >50% is required; strong communication and cross‑functional collaboration are essential.

Formación

• RequiresBachelor’s degree in Engineering or related field.
• 7–10 years in quality assurance/QMS in medical devices.
• Experience with ISO 13485 and FDA inspections.
• Ability to discuss and resolve complex regulatory compliance issues.

Responsabilidades

• Lead Quality Management System activities for global harmonization and regulatory compliance.
• Develop and train HT employees on quality requirements and awareness.
• Ensure execution of the Quality Plan and objectives.
• Lead CAPA process and metrics across HT facilities.
• Oversee internal audits and manage external regulatory inspections (FDA, Notified Bodies).
• Improve quality agreement templates and negotiate supplier quality terms; travel >50%.

Conocimientos

ISO 13485

FDA 21 CFR 820

Leadership

Regulatory audits

Cross-functional

Educación

Bachelor’s degree

Herramientas

CAPA tools

Descripción del empleo

Celestica Inc. in Monterrey, MX seeks a Global QMS Manager to lead the Quality Management System activities for regulatory harmonization and compliance across sites.

This role trains HT employees, ensures execution of the Quality Plan, and leads CAPA processes with senior leadership interface. Travel >50% is required; strong communication and cross‑functional collaboration are essential.