Senior Commercial Quality Analyst, Medical Devices

Johnson & Johnson Co.; Bogotá; Sur place; COP 36 000 000 - 52 000 000; Plein temps

Résumé du poste

Johnson & Johnson Bogotá seeks a Surgery Commercial Quality Sr. Analyst to ensure compliance with the Quality Management System, drive improvements, and support cross-functional LATAM initiatives.

You will handle technovigilance, post-market surveillance, CAPA, and product complaints while applying SAP master data, documentation control, and training processes to ensure patient safety and regulatory readiness.

Qualifications

• Bachelor’s degree in a scientific or engineering field is required.
• Experience with Quality Management Systems in regulated settings.
• Knowledge of technovigilance, post-market surveillance, CAPA and non-conformance management.
• Experience in Medical Devices or pharma/regulatory environments preferred.
• English proficiency for regional/global collaboration.

Responsabilités

• Maintain compliance with Quality Management System policies and standards.
• Investigate non-conformances and define corrective actions via root cause analysis.
• Manage document control, records management, and change control processes.
• Support regulatory inspections and internal audits.
• Assist in training, samples management, and onboarding processes.

Connaissances

English proficiency

Analytical skills

Cross-functional collaboration

Project ownership

Formation

Bachelor’s degree in Pharmaceutical Chemistry / Biomedical Engineering / Chemical Engineering

Outils

SAP

Master Data

Document control systems

Description du poste

Johnson & Johnson Bogotá seeks a Surgery Commercial Quality Sr. Analyst to ensure compliance with the Quality Management System, drive improvements, and support cross-functional LATAM initiatives.

You will handle technovigilance, post-market surveillance, CAPA, and product complaints while applying SAP master data, documentation control, and training processes to ensure patient safety and regulatory readiness.