Lead Design Assurance Quality Engineer (Medical Devices)

Location: Hybrid in Kaunas, Lithuania; approximately 3 days per week in the Kaunas office

Salary: €3,100–€4,500 gross per month

Company

hirify.global is an independent, employee-owned healthcare products company developing, manufacturing, and marketing products for ostomy care, continence care, and critical care worldwide.

What you will do

• Represent Quality Management on new product development and change management project core teams.
• Guide cross-functional teams in applying design controls and meeting global medical device regulatory requirements.
• Facilitate design and process verification and validation activities, including specification and test method development.
• Lead design FMEA, participate in process FMEA, and conduct risk assessments in line with ISO 14971.
• Own Usability Engineering Files and support clinical, design verification, validation, preproduction, and first article reviews.
• Apply statistical methods and mentor others in Quality Engineering principles and practices.

Requirements

• Bachelor’s degree and 8–12 years of related experience; further education may reduce the experience requirement.
• Experience in Quality Engineering and/or new product development or R&D, preferably in the medical device industry.
• Knowledge of design controls, validation, FMEA, human factors engineering, and medical device risk management.
• Experience with EU MDD/MDR directives and regulations and an ISO 13485 environment.
• Working knowledge of statistics and statistical tools such as Statistica, Minitab, and Excel.
• Project management training or experience.

Nice to have

• ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer certification.
• Advanced statistics training and experience with plastic injection molding and automated assembly processes.

Culture & Benefits

• Learning and development-oriented culture.
• Annual performance-based bonus.
• Health insurance and 24/7 accident insurance.
• Flexible working hours.
• Subsidized fresh breakfast and lunch at the site restaurant.
• Team-building activities, summer festivals, special events, and free electric vehicle charging stations.