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Quality Management System Analyst

Medellin, Antioquia, Colombia

Job Type

Full-time employment

Workspace

Strategic Direction

About the Role

If you're passionate about quality, continuous improvement, and making a real impact in the medical device industry, this opportunity is for you.

This role is key to ensuring our Quality Management System remains effective and aligned with ISO 13485 and applicable regulatory standards. You'll collaborate across teams, guide best practices, and support our commitment to delivering safe, high-quality products to our customers.

Primary responsibilities:
Keep the Quality Management System updated according to ISO 13485.
Address and monitor customer complaints.
Support post-market surveillance management of medical devices.
Monitor key Performance Indicators (KPIs) and Objectives and Key Results (OKRs)
Support the design of work instructions, processes, and procedures
Generate control strategies for process compliance
Make quality processes visible to promote the corporate quality culture
Guide the personnel on the Quality Management System, advise on the construction of documents, raising of non-conformities, construction of action plans, and closure of corrective and preventive actions.
Execute the functions of internal auditor, promoting good practices in the organization culture

Requirements

  • US Visa

  • English - C1

  • Professional in Biomedical Engineering or related careers.

  • ISO 13485:2016 knowledge

  • Desired: 21 CFR 820 knowledge

  • Desired: ED MDR 2017/745

Diseño
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Digital Surgery planning and solutions that are customized to your patient's needs.

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TECHFIT HQ

1511 Aviation Center Pkwy

Suite 220H 

Daytona Beach, FL 32114

United States

Tel +1 (386) 872-0872

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