Quality Systems Specialist – Regulated IT & Validation

Medtronic plc; Puerto Bogotá; Hybrid; COP 159,139,000 - 254,623,000; Full time

Job summary

Medtronic plc in Bogotá, Colombia seeks a Quality Systems Specialist to serve as an independent quality representative for regulated IT projects. You will review validation and lifecycle documentation, provide guidance to project teams, assess compliance risks, and help ensure solutions meet quality and regulatory requirements.

You’ll engage with a broad portfolio, including cloud solutions and data platforms, collaborating with global stakeholders in a hybrid, international team.

Qualifications

• Bachelor's degree in a related field with 2+ years in quality, compliance, validation, or regulated environments.
• Experience reviewing validation deliverables for regulated IT/medical device systems.
• Knowledge of validation lifecycle methodologies and risk-based validation.

Responsibilities

• Review validation deliverables, testing docs, 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 for alignment with quality processes and regulatory requirements.
• Partner with global stakeholders to implement compliant IT systems and processes.
• Assess requirements, testing evidence, and risk management to verify readiness for deployment.
• Support audit readiness activities, CAPA investigations, supplier quality initiatives, and regulatory reviews.
• Contribute to continuous improvement initiatives strengthening quality, compliance and validation practices.
• Collaborate with cross-functional teams across regions in a global virtual environment.

Skills

Advanced English proficiency

Quality systems

Regulatory compliance

Education

Bachelor's degree

Job description

Medtronic plc in Bogotá, Colombia seeks a Quality Systems Specialist to serve as an independent quality representative for regulated IT projects. You will review validation and lifecycle documentation, provide guidance to project teams, assess compliance risks, and help ensure solutions meet quality and regulatory requirements.

You’ll engage with a broad portfolio, including cloud solutions and data platforms, collaborating with global stakeholders in a hybrid, international team.