Staff Quality Engineer – Manufacturing Site

About the role

The Staff Quality Engineer will support the Manufacturing Site in Grecia, ensuring that all products and processes meet the highest quality standards and comply with regulatory requirements such as FDA GMP, ISO 13485 and MDSAP. Working independently and within cross‑functional teams, you will help safeguard product safety, minimize defects, and maintain market access.

Key responsibilities

• Escalate and resolve quality issues, coordinating with QA, engineering, production and other departments.
• Contain non‑conforming products through identification, segregation and reconciliation.
• Participate in cross‑functional investigations, risk assessments, historical record reviews and corrective‑action planning.
• Monitor, trend and report quality data to management.
• Interpret and apply Failure Modes and Effects Analysis (FMEA) and other risk‑management tools.
• Own corrective actions (CAPA) and ensure compliance with the Quality Management System.
• Develop statistical sampling plans to verify effectiveness of controls.
• Evaluate and implement changes to the electronic Quality Management System (eQMS) for regulatory compliance.
• Support internal and external audits and address audit findings.

Required profile

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 5 years of experience in Quality Engineering, preferably in medical devices.
• Proficiency in English (written and verbal).
• General knowledge of 21 CFR 820, ISO 13485 and MDSAP.
• Strong computer skills with Microsoft Word, Excel and internet applications.

Required skills

• Microsoft Word
• Microsoft Excel
• Internet research and documentation tools
• Failure Modes and Effects Analysis (FMEA)
• Statistical sampling methods
• Corrective and Preventive Action (CAPA) management
• Electronic Quality Management System (eQMS) administration
• Regulatory standards: 21 CFR 820, ISO 13485, MDSAP