Senior Quality Assurance Engineer I

About the role

We are looking for a Senior Quality Assurance Engineer to join our Kaunas site, ensuring regulatory compliance and supporting continuous improvement of our medical-device manufacturing processes.

Key responsibilities

• Maintain compliance with all regulatory requirements of the Quality System.
• Support internal and external audits.
• Plan, coordinate, execute and document validation studies, risk analyses (e.g., FMEA), process capability studies and drive process improvements.
• Investigate customer complaints and CAPA items, perform root-cause analysis and implement corrective actions.
• Collaborate with operations to achieve plant Global Quality Management objectives aligned with Hollister’s mission and vision.

Required profile

• 2-5 years of experience in quality engineering within medical-device, pharmaceutical, biotech or related industries.
• Degree in Engineering, Mathematics, Natural Sciences, Computer Science or a related technical field.
• Experience with self-directed work teams is a plus.
• Strong command of English.

Required skills

• Validation study execution and documentation.
• Risk analysis methods, including FMEA.
• Process capability assessment.
• Knowledge of systematic injection molding techniques and film sealing (preferred).
• CAPA management.

What we offer

• Learning-and-development oriented culture.
• Annual performance-based bonus.
• Comprehensive health-insurance benefits.
• Flexible working hours.
• Subsidised fresh breakfast and lunch at the site restaurant.
• Team-building events, summer festivals and special activities.
• Free electric-car charging stations.
• 24/7 accident insurance.