Quality Systems Engineer (CAPA & ISO 13485)

Ambu; Abasolo; Presencial; MXN 420.000 - 700.000; Jornada completa

Descripción de la vacante

Ambu is expanding its Manufacturing Site in Mexico. The Quality System Engineer will support the organization by maintaining CAPA, NCR, and Planned Deviation processes, ensuring inspection readiness, and applying ISO 13485 standards.

The role involves coaching teams on QMS processes, leading quality projects with cross-functional teams, and maintaining quality records and metrics to drive continuous improvement at the site.

Formación

• Bachelor’s degree in a related field.
• 3+ years of relevant work experience in the medical device field.
• 1+ years of experience working in Quality Systems, preferred.
• Hands on knowledge of ISO 13485.
• Experience working in manufacturing preferred.
• Must be able to read, write and understand English.

Responsabilidades

• Ensure compliance of CAPA, NCR, and Planned Deviation processes.
• Serve as site trainer for CAPA and Nonconformances systems.
• Provide coaching and guide teams to follow QMS processes.
• Lead quality projects with cross functional teams.
• Maintain quality records on product testing and stakeholder input.
• Facilitate tracking and closure of Nonconformances to ensure compliance.
• Support development and rollout of standardized QMS data sources and metrics.

Conocimientos

CAPA management

NCR handling

ISO 13485

Quality systems

Auditing

English proficiency

Cross-functional teamwork

Educación

Bachelor’s degree in related field

Descripción del empleo

Ambu is expanding its Manufacturing Site in Mexico. The Quality System Engineer will support the organization by maintaining CAPA, NCR, and Planned Deviation processes, ensuring inspection readiness, and applying ISO 13485 standards.

The role involves coaching teams on QMS processes, leading quality projects with cross-functional teams, and maintaining quality records and metrics to drive continuous improvement at the site.