Quality Engineer - Medical Devices & QMS Innovator

Sanner America (formerly Gilero); Tijuana; Presencial; MXN 240.000 - 420.000; Jornada completa

Descripción de la vacante

Gilero, A Sanner Company, partners with Tecma, operates a medical device facility in Tijuana, Mexico. Gilero seeks a Quality Engineer to drive QMS effectiveness, CAPA processing, and continuous improvement in a fast-paced environment.

The role requires collaboration with Engineering, Manufacturing, and Regulatory teams to ensure product quality and regulatory compliance across development and production activities.

Formación

• Bachelor’s degree in Biomedical, Industrial, Mechanical or related field.
• Minimum 3 years in a regulated industry (medical devices, pharmaceuticals, or similar).
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Experience with CAPA, NCRs, and regulatory audits.
• Ability to read technical drawings and use precision measurement tools.
• Proficient in Microsoft Office; ERP/QMS experience a plus.

Responsabilidades

• Support QMS development and maintenance per ISO 13485 and FDA 21 CFR Part 820.
• Investigate NCRs, perform root cause analysis, and implement CAPAs.
• Participate in internal and regulatory audits.
• Collaborate with Engineering, Manufacturing, and Regulatory teams to meet quality requirements.
• Review DHRs, incoming inspections, and batch documentation.
• Develop and validate measurement techniques for in-process and finished products.
• Assist with supplier quality tasks and containment actions.
• Contribute to continuous improvement initiatives to enhance quality and efficiency.

Conocimientos

Teamwork

Communication

Attention to detail

Regulatory knowledge

Educación

Bachelor's degree in Biomedical, Industrial, Mechanical or related field

Herramientas

Calipers

Micrometers

Optical comparators

ERP systems

Descripción del empleo

Gilero, A Sanner Company, partners with Tecma, operates a medical device facility in Tijuana, Mexico. Gilero seeks a Quality Engineer to drive QMS effectiveness, CAPA processing, and continuous improvement in a fast-paced environment.

The role requires collaboration with Engineering, Manufacturing, and Regulatory teams to ensure product quality and regulatory compliance across development and production activities.