Quality System Specialist. (Bogotá, D.C.)

Quality System Specialist. (Bogotá, D.C.)

30 sep
|
COS Medtronic Shared Services Americas
|
Bogotá, D.C.

30 sep

COS Medtronic Shared Services Americas

Bogotá, D.C.

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life Responsibilities 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 general 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 initiatives of the organiz

📌 Quality System Specialist. (Bogotá, D.C.)
🏢 COS Medtronic Shared Services Americas
📍 Bogotá, D.C.

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