Quality Systems Specialist - Regulated IT Validation

About the role

Medtronic is looking for a Quality Systems Specialist in Bogotá, Colombia, working under a flexwork model. As an independent quality representative, you will support regulated IT projects across the organization by reviewing validation and lifecycle documentation, giving guidance to project teams, assessing compliance risks and helping ensure technology solutions meet quality and regulatory requirements. The role exposes you to cloud solutions, data platforms, automation and emerging digital initiatives.

Key responsibilities

• Review and assess validation deliverables, testing documentation, risk assessments and system lifecycle records for regulated IT solutions.
• Provide quality and validation guidance to project teams throughout planning, execution and implementation.
• Evaluate project documentation against quality processes, regulatory requirements and internal standards.
• Partner with global stakeholders to implement compliant IT systems and processes.
• Assess requirements, testing evidence and risk management activities to verify readiness for system deployment.
• Support audit readiness, CAPA investigations, supplier quality initiatives and regulatory assessments as needed.
• Contribute to continuous improvement of quality, compliance and validation practices.
• Collaborate with cross-functional teams across regions in a global virtual environment.

Required profile

• Bachelor's degree and 2+ years of experience in quality, compliance, validation or regulated environments such as medical devices, pharmaceuticals, life sciences, manufacturing or related industries.
• Experience reviewing, executing or approving validation deliverables for regulated systems.
• Experience supporting validation activities throughout the regulated IT system lifecycle.
• Advanced English proficiency and the ability to collaborate with global stakeholders.

Required skills

• Knowledge of validation lifecycle methodologies and risk-based validation principles.
• Preferred: knowledge of ISO 13485, FDA 21 CFR Part 11 and EU Annex 11.
• Preferred: experience with audit support, CAPA, supplier quality and regulatory reviews, and project management experience.

What we offer

• A competitive salary and a flexible benefits package.
• Eligibility for the Medtronic Incentive Plan (MIP).