Quality Engineer, Medical Devices & QMS Expert

Gilero, A Sanner Group Company; Tijuana; Presencial; MXN 420.000 - 540.000; Jornada completa

Descripción de la vacante

Gilero, A Sanner Company is seeking a Quality Engineer for its medical device manufacturing facility in Tijuana, Mexico. You will ensure continuous improvement of quality systems while supporting the design, development, transfer, and production of medical devices and combination products.

You will collaborate with Engineering, Manufacturing, and Regulatory teams to meet quality requirements, participate in audits, review DHRs, and support CAPA and NCR investigations.

Formación

• Bachelor’s degree in Biomedical, Industrial, Mechanical or related technical field.
• Minimum 3 years of experience in a regulated industry (preferably medical devices, pharmaceuticals, or similar manufacturing environments).
• Knowledge of ISO 13485 and FDA 21 CFR Part 820.
• Familiarity with inspection tools such as calipers, micrometers, optical comparators, and other precision measurement equipment.
• Ability to read and interpret technical drawings, specifications, and inspection instructions.
• Understanding of validation principles (IQ, OQ, PQ) and quality assurance methodologies.
• Exposure to CAPA processes and root cause analysis tools.
• Proficiency in Microsoft Office; ERP or QMS systems is a plus.

Responsabilidades

• Support the development, implementation, and maintenance of the Quality Management System (QMS) in ISO/FDA compliance.
• Assist in investigation and documentation of NCRs, root cause analysis, and CAPA implementation.
• Participate in internal audits and help prepare documentation for regulatory and customer audits.
• Collaborate with Engineering, Manufacturing, and Regulatory teams to meet quality requirements.
• Review and approve Device History Records (DHRs) and production batch documentation.
• Develop and validate measurement techniques for in-process and finished products.
• Support production line troubleshooting and containment of quality issues.
• Participate in IQ/OQ/PQ validation of processes, equipment, and QC systems.
• Contribute to writing/updating quality procedures and work instructions.
• Assist with supplier quality tasks including incoming inspections.

Conocimientos

Quality systems

Regulatory compliance

Root cause analysis

CAPA processes

Measurement techniques

Reading drawings

Educación

Biomedical/Industrial/Mechanical degree

Herramientas

Calipers

Micrometers

Optical comparators

Descripción del empleo

Gilero, A Sanner Company is seeking a Quality Engineer for its medical device manufacturing facility in Tijuana, Mexico. You will ensure continuous improvement of quality systems while supporting the design, development, transfer, and production of medical devices and combination products.

You will collaborate with Engineering, Manufacturing, and Regulatory teams to meet quality requirements, participate in audits, review DHRs, and support CAPA and NCR investigations.