Senior Quality Assurance Engineer (MedTech)

TL;DR

Senior Quality Assurance Engineer (MedTech): Ensuring regulatory compliance and quality standards for healthcare products with an accent on validation studies, risk analysis, and CAPA management. Focus on partnering with operations to achieve global quality objectives and driving process improvements within a manufacturing environment.

Location: Kaunas, Lithuania (Onsite)

Salary: €2,400–€3,700 gross per month

Company

hirify.global Incorporated is an independent, employee-owned global healthcare company dedicated to developing and marketing innovative products for ostomy, continence, and critical care.

What you will do

• Maintain regulatory compliance within the Quality System.
• Support internal and external quality audits.
• Plan, execute, and document validation studies and risk analyses like FMEA.
• Manage customer complaints and CAPA processes, including root cause analysis.
• Collaborate with operations to meet global quality management objectives.

Requirements

• 2–5 years of experience in quality engineering within medical device, pharmaceutical, or related industries.
• Degree in Engineering, Math, Natural Sciences, or Computer Science.
• Strong understanding of validation studies and process improvements.
• English language proficiency required.
• Must be based in or able to work onsite in Kaunas, Lithuania.

Nice to have

• Technical knowledge in injection molding techniques and film sealing.
• Experience working with self-directed work teams.

Culture & Benefits

• Learning and development-oriented environment.
• Annual performance-based bonus.
• Comprehensive benefits package including health and 24/7 accident insurance.
• Flexible working hours and onsite restaurant with subsidized meals.
• Supportive culture with team-building events and electric car charging stations.