Analista de Sistema de Gestión de Calidad
On-site
Core
Managing Quality Management System (SGC) documentation, ensuring compliance with ISO 13485 and Good Documentation Practices (GDP), and supporting internal/external audits.
Role type
Quality Management System Analyst
Builds
Quality Management System documentation and compliance records
Domain
Medical devices / Quality Assurance
Deliverable
dashboards & analysis
Required skills
ISO 13485, Good Documentation Practices (GDP), CAPA management, audit support, document control, corrective and preventive actions
Preferred skills
None stated
Technologies
Office suite
Responsibilities
Administer and update SGC documentation, maintain master lists and records, track CAPA and change controls, verify GDP compliance, support internal/external audits, control obsolete documents, prepare reports for continuous improvement