Are you passionate about quality and compliance in the medical device industry? Join our team as a Quality Management System Coordinator and play a key role in ensuring our systems meet top regulatory standards like ISO 13485 and 21 CFR 820.

We're looking for a detail-oriented professional with strong knowledge in QMS processes and a drive for continuous improvement. If you're ready to guide teams, monitor critical quality activities, and support our mission of excellence, this could be your next big opportunity.

Primary Responsibilities

• Coordinate and keep the QMS updated per ISO 13485, 21 CFR 820, 29 CFR 1910, and applicable regulatory requirements.
• Ensure that the processes and procedures necessary for the quality management system are established, implemented and maintained.
• Direct and monitor complaints/suggestions.
• Guide staff on the Quality Management System, advise on the construction of documents, raising non-conformities, construction of action plans, and corrective and preventive actions.
• Monitor the effectiveness of the actions originated from: Postmarket Surveillance, internal and external audits, and Management Review Meeting.

Requirements:

• US Visa
• English - C1
• Professional in Biomedical Engineering or related careers.
• 1 year in related positions
• ISO 13485:2016 knowledge
• Desired: 21 CFR 820 knowledge
• Desired: ED MDR 2017/745

Place: 

On-site/virtual | Medellín Colombia