Quality Manager – Colombia & DX Countries

About the role

Abbott is seeking a Quality Manager to lead quality and regulatory activities for its Diabetes Care division in Colombia and other DX markets. Based in Bogotá, you will ensure the Quality Management System meets Abbott, local and international standards while acting as the primary liaison with INVIMA.

Key responsibilities

• Support the division in delivering field quality compliance and implement relevant policies.
• Report non‑compliance issues and monitor local regulations affecting the business.
• Serve as the main contact with INVIMA for medical‑device matters, generating surveillance reports and responding to authority requests.
• Establish, implement and maintain the QMS at the commercial affiliate, ensuring alignment with Abbott Quality & Regulatory (AQR) and ADC procedures.
• Manage the retention schedule of quality records in line with local legislation and Abbott requirements.
• Conduct management reviews and communicate significant compliance, regulatory, quality, supply or safety events to regional QA.

Required profile

• Proven experience in quality management and regulatory oversight for medical devices.
• Strong knowledge of Colombian health‑authority requirements (INVIMA) and applicable international standards.
• Ability to interact with health authorities and manage product lifecycle compliance.
• Experience in maintaining QMS documentation, record retention and conducting management reviews.

Required skills

What we offer

• Career development within a global healthcare leader.
• Access to international training and growth opportunities.
• Recognition as a top employer for diversity and work‑life balance.