Quality Systems Specialist

About the role

The Quality Systems Specialist supports the implementation, maintenance, and continuous improvement of Medtronic's Quality Management System (QMS) across Latin America. Working remotely from Bogotá, you will ensure compliance with regulatory requirements, internal standards, and corporate policies while collaborating with global teams.

Key responsibilities

• Review and process Change Requests in the Product Lifecycle Management (PLM/MAP) system, adhering to QMS and Good Documentation Practices.
• Partner with stakeholders in the Americas and EurAsia to resolve quality system inquiries and maintain effective collaboration.
• Monitor quality system processes, ensuring compliance with internal policies, regulatory requirements, and established standards.
• Analyze quality data, identify trends, and drive continuous‑improvement projects, including CAPA activities.
• Support audits and inspections by preparing documentation, addressing findings, and coordinating with auditors.
• Prepare reports and communicate updates, recommendations, and key metrics to relevant stakeholders.
• Deliver training and ongoing support on quality system processes to promote best practices across global teams.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, or a related scientific field.
• 1‑2 years of experience in Quality Systems with a solid understanding of QMS processes.
• Experience with document control and Good Documentation Practices.

Required skills

• Product Lifecycle Management (PLM) system usage.
• Quality Management System (QMS) processes.
• Document Control.
• Good Documentation Practices (GDP).
• Corrective and Preventive Action (CAPA) management.