Quality Assurance Engineer – Medical Devices

About the role

We are looking for a Quality Assurance Engineer to join our Global Quality Management Operations team in Ballerup, Denmark. The role will support the CAPA process and help ensure that Ambu’s medical devices meet the highest quality and regulatory standards.

Key responsibilities

• Collaborate with a team of seven quality professionals to drive improvement projects and cross‑functional initiatives.
• Participate in global quality forums, provide support to local manufacturing sites, and communicate findings to management.
• Monitor quality issues across processes, analyse customer complaints, and identify corrective actions.
• Maintain and update SOPs related to quality processes.
• Support optimisation projects within Quality Management Operations.

Required profile

• 3–5 years of experience in a quality role within the medical‑device industry.
• Academic background in engineering, science or related field (BSc/MSc).
• Strong interest in quality, collaborative mindset and business‑partner attitude.
• Excellent written and spoken English.

Required skills

• CAPA process management.
• Management Review.
• LEAN principles.
• Project management.
• KPI development and performance monitoring.
• Knowledge of ISO 13485, EU MDR, MDSAP and UK MDR.