Quality Engineer – Medical Devices

About the role

We are seeking a Quality Engineer to ensure our medical device products meet the highest quality standards. The role involves supporting audits, managing quality records, and driving continuous improvement across the plant.

Key responsibilities

• Verify that processes and products comply with specifications and quality standards.
• Support internal and external audits and maintain audit documentation.
• Manage retention, storage, and release of quality records and products.
• Maintain and improve the Quality Management System (QMS) and ensure full traceability of batches, components, and processes.
• Develop and monitor performance metrics and plant indicators.
• Identify gaps in the quality system and implement corrective actions.
• Lead continuous improvement initiatives and manage customer complaints.
• Define inspection and testing plans, assess risks to patients, users, and products, and participate in Material Review Board meetings.

Required profile

• Bachelor’s degree in Industrial Production, Materials, Chemical, Electromechanics or a related field.
• 3‑5 years of experience in the medical device industry.
• Knowledge of ISO 13485 and FDA QSR 21 CFR Part 820 and Part 11.
• Intermediate to advanced English proficiency (B2‑C1).
• Strong teamwork, learning agility, and ability to manage multiple projects.

Required skills

• ISO 13485 implementation and maintenance.
• FDA QSR 21 CFR Part 820 compliance.
• FDA 21 CFR Part 11 electronic records handling.
• ERP system reporting and transaction generation.