Quality Assurance Engineer - Medical Devices, GMP & QMS

Oferta confidencial; Tijuana; On-site; MXN 180,000 - 240,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality assurance

Data analysis

Regulatory compliance

GMP ISO 13485 familiarity

CAPA management

Documentation control

Tools

QMS software

PFMEA

Statistical analysis

Job description

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.