Quality System Specialist.Postuler: Mode de travail Versátil Work Arrangement: Bogotá, Bogota, Colombia: Temps plein: Offre publiée aujourd'hui: Date de fin : 30 septembre 2026 (Il reste 7 jour(s) pour postuler): R77079Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.Journée typeResponsibilities may include the following and other duties may be assigned:* Execution of Complaint Handling activities: Regulatory decisions and regulatory reporting (drafting and submission)* Execute tasks using Complaint Handling tools/systems (Global Complaint Handling system)* Ensure closure of regulatory reports with investigation are done timely, consistently and in compliance with regulatory requirements.* Respond to stakeholder inquiries regarding status of regulatory decisions and reports* Assist in training new personnel on system activities,
including complaint handling, regulatory reporting, and CAPA management* Monitor regulatory reporting deadlines and ensure all reports are submitted on time to relevant authorities* Review and verify the accuracy and completeness of regulatory reports before submission* Participate in CAPA investigations to identify root causes of quality issues and deviations* Perform activities within the system to document CAPA activities from stakeholders and global operations units* Monitor adherence to documented processes and procedures outlined in the QMS. Regularly audit processes to identify any deviations or non-compliance issues and take corrective actions as necessary* Participate in projects, process improvement initiatives & respond to stakeholder’s additional requests* Review complaint information and assess if the complaint is reportable to the appropriate regulatory bodies* Participation in tech/automation