Quality Systems Engineer: CAPA & Audit Expert

Corza Medical; Tijuana; Presencial; MXN 360.000 - 600.000; Jornada completa

Descripción de la vacante

Corza Medical in Mexico seeks a Quality Assurance professional to lead CAPA and internal audit activities within a regulated medical device environment. You will maintain the Internal Audit Program, support external audits, and drive continuous improvement across the Quality System.

This role requires 3–5 years of QMS experience, proficiency with eQMS, and strong English and Spanish communication. You will collaborate across teams, investigate CAPA root causes, prepare documentation and metrics,

Formación

• Bachelor's degree in a science, technical discipline or equivalent experience.
• 3–5 years of QMS experience in medical devices or regulated environments.
• Strong English and Spanish communication skills.

Responsabilidades

• Create and maintain yearly Internal Audit Program.
• Support coordination and readiness for External Audits (Customer, Notify Body, Inspections).
• Help ensure readiness for internal, external audits and inspections.
• Participate in development and maintenance of Internal Lead Auditor Certification.
• Monitor and maintain CAPA activities and program.
• Assist in CAPA investigations and follow-up actions as needed.
• Provide guidance on internal audit and CAPA processes.
• Prepare quality documentation, metrics, and reports.

Conocimientos

QMS experience

Audit coordination

CAPA process

GMP/GDP knowledge

Cross-functional collaboration

Educación

Bachelor's degree in science/technical field

Herramientas

eQMS

Descripción del empleo

Corza Medical in Mexico seeks a Quality Assurance professional to lead CAPA and internal audit activities within a regulated medical device environment. You will maintain the Internal Audit Program, support external audits, and drive continuous improvement across the Quality System.

This role requires 3–5 years of QMS experience, proficiency with eQMS, and strong English and Spanish communication. You will collaborate across teams, investigate CAPA root causes, prepare documentation and metrics,