Quality Assurance Engineer - Medical Devices, GMP & QMS

Oferta confidencial; Tijuana; Presencial; MXN 180.000 - 240.000; Jornada completa

Descripción de la vacante

Oferta confidencial in Mexico is seeking a Quality Assurance professional to analyze customer data, audit materials and processes, and maintain GMP/ISO13485 standards across manufacturing.

The role includes supporting QMS documentation, local and global CAPA activities, KPI monitoring, audits, change control, and training to ensure product conformance and regulatory compliance with FDA/GM P guidelines.

Formación

• 3-5 years experience in QMS of Medical Device Manufacturer.
• Experience with FDA/ GMP guidelines.
• Ability to analyze data and monitor KPIs.
• Experience with CAPA processes.

Responsabilidades

• Analyze customer data, complaints and issues; audit materials and processes.
• Maintain GMP/ISO13485 standards across manufacturing.
• Surveillance of calibration equipment and processes; process validation support.

Conocimientos

Quality assurance

Data analysis

Regulatory compliance

GMP ISO 13485 familiarity

CAPA management

Documentation control

Herramientas

QMS software

PFMEA

Statistical analysis

Descripción del empleo

Oferta confidencial in Mexico is seeking a Quality Assurance professional to analyze customer data, audit materials and processes, and maintain GMP/ISO13485 standards across manufacturing.

The role includes supporting QMS documentation, local and global CAPA activities, KPI monitoring, audits, change control, and training to ensure product conformance and regulatory compliance with FDA/GM P guidelines.