Senior Quality Engineer

About the role

We are looking for a Senior Quality Engineer to lead investigations of non‑conformances, implement corrective actions, and ensure our medical device products meet the highest quality standards.

Key responsibilities

• Lead investigations of non‑conformances and drive corrective and preventive actions.
• Collaborate with Engineering, Production and cross‑functional teams to meet quality requirements.
• Support internal and external audits, prepare documentation and address observations.
• Manage containment activities for non‑conforming product, including identification and segregation.
• Monitor, analyze and trend quality data to identify risks and improvement opportunities.
• Apply statistical analysis and risk management tools such as FMEA.

Required profile

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 3 years of experience in Quality Engineering.
• Working knowledge of 21 CFR Part 820, ISO 13485 and MDSAP.
• Advanced English proficiency, written and verbal.

Required skills

• 21 CFR Part 820 compliance
• ISO 13485 compliance
• MDSAP knowledge
• Failure Mode and Effects Analysis (FMEA)
• Statistical analysis
• Quality risk management tools