Quality Specialist LATAM

About the role

Vantive is seeking a Quality Specialist for the Latin America region to ensure compliance with internal and external audit programs related to medical device distribution in Colombia. The role supports continuous improvement and regulatory adherence across the supply chain.

Key responsibilities

• Guarantee timely release of imported finished products in line with Decreto 4725 of 2005.
• Ensure compliance with the Certificate of Storage and Conditioning (CCAA) requirements.
• Provide operational and documentary support for medical device management in Colombia.
• Coordinate audit preparation, execution, and closure, meeting regulatory, normative, and corporate standards.
• Track corrective and preventive actions (CAPA) from audits, ensuring proper implementation and traceability.
• Maintain up‑to‑date audit documentation, including procedures, records, reports, and action plans.

Required profile

• Biomedical Engineering degree or related field.
• Minimum 3 years of experience in quality management systems, audits, logistics, or medical device support.
• Knowledge of ISO 9001, ISO 13485, and applicable health‑sector quality standards.
• Familiarity with internal and external audit processes.
• Experience with document management systems.
• Basic to intermediate understanding of Colombian medical device regulations.

Required skills

• ISO 9001
• ISO 13485
• Audit management
• Document management systems
• CAPA processes