Quality System Specialist.
Medtronic · Bogota, Colombia
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Medtronic seeks a Quality System Specialist in Bogotá to manage complaint handling, regulatory reporting, and post-market surveillance activities within the medical device quality assurance function. The role involves executing compliance tasks, investigating quality issues, and ensuring adherence to regulatory and quality management system requirements.
What they're looking for
- Bachelor's degree in medical, biological, pharmaceutical science, engineering, or related field
- Fluent English proficiency
- 2-3 years experience in post-market surveillance, vigilance, or QA/RA roles
- Proficiency with MS Office Suite
- Understanding of GDP implementation and ISO 13485 standards
- Knowledge of regulatory requirements for adverse event reporting on approved devices
What you'll be doing
- Execute complaint handling and regulatory reporting activities including drafting and timely submission to authorities
- Participate in CAPA investigations to identify root causes of quality issues and document findings
- Monitor compliance with quality management system processes and conduct audits to identify deviations
- Review complaint information and assess reportability to appropriate regulatory bodies
- Respond to internal and external audit inquiries and ensure follow-up on corrective actions
Privacy & handoff
This role links to Medtronic's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.