Quality Assurance Officer – Medical Devices

This is a fully remote position, open to applicants in Portugal.

📋 Description

• Engage in the establishment and execution of Quality Management Systems (QMS).

• Develop Technical Documentation for medical devices (MDs) and software as a medical device (SaMDs) intended for submission to Notified Bodies for CE marking.

⛳️ Requirements

• Qualified professionals (QNQ level 6–8) with a minimum of 1 year of experience in Quality Management & Assurance.

• Proven experience in creating and implementing Quality Management Systems in compliance with ISO 9001, EN ISO 13485, EN 14971, and EN 62366.

• Bachelor’s degree or higher in Health Sciences or Biomedical Technology.

• Proficient in both English and Portuguese.

• Excellent scientific writing capabilities.

• Comprehensive understanding of the EU regulatory landscape for medical devices.

• Experience in applying EN 62304 requirements within a Quality Management System.

• Background in preparing Technical Documentation for CE marking of SaMDs.

• Self-motivated, highly organized, and oriented towards problem-solving.

🏝️ Benefits

• Contribute to highly innovative products that can significantly impact people's lives.

• Enjoy a positive, politics-free work environment founded on lean principles and self-organization.

• Access to continuous training and opportunities for both professional and personal growth.

• Competitive salary and benefits.