Senior Quality and Technical Associate

Senior Quality & Technical Associate – Bogota, Colombia

Responsible for implementing and maintaining quality systems across the region, ensuring compliance with local regulations, acting as the technical responsible before INVIMA, and overseeing post-market surveillance, field actions, complaint handling, CAPA, product release, and related quality activities.

Responsibilities

• Support management of the quality system: perform quality audits; develop, maintain SOPs; generate and draft quality agreements across region.
• Inspect and release products in Colombia and Panama according to procedures and local regulations.
• Coordinate and execute field actions, perform complaint handling and reporting to MoH; CAPA and communications with customers and distributors.
• Support the INVIMA CCAA process and Reactivovigilance, Technovigilance activities including adverse event reporting.
• Act as Technical Director in Colombia ...