Lead Design Assurance Quality Engineer (Medtech)

TL;DR

Lead Design Assurance Quality Engineer (Medtech): Managing quality assurance for new product development and change management in medical devices with an accent on design controls and regulatory compliance. Focus on executing design/process verification and validation, conducting risk assessments (FMEA), and applying statistical analysis to ensure product qualification.

Location: Hybrid (Kaunas, Lithuania) - requires presence in the office approximately 3 days per week

Company

Independent, employee-owned company developing and manufacturing innovative healthcare products for ostomy, continence, and critical care worldwide.

What you will do

• Guide cross-functional teams in applying design controls per global medical device regulatory requirements.
• Facilitate design and process verification/validation for new products and significant changes to existing processes.
• Conduct risk assessments and facilitate design/process FMEA in compliance with ISO 14971.
• Manage Usability Engineering Files and support clinical design verification and validation.
• Apply parametric and nonparametric statistical analysis (ANOVA, DOE, etc.) to ensure products are qualified prior to market release.
• Mentor and train team members on Quality Engineering principles and practices.

Requirements

• Bachelor’s Degree with 8-12 years of related experience.
• Must be based in or be able to work from the Kaunas, Lithuania office.
• Experience in the medical device industry, specifically in Quality Engineering or R&D.
• Knowledge of EU MDD/MDR directives and ISO 13485 standards.
• Proficiency in statistical tools such as Statistica, Minitab, or Excel.
• Experience with Design Controls, human factors engineering, and risk management (ISO 14971).

Nice to have

• ASQ Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE).
• Advanced statistics training and experience with plastic injection molding and automated assembly processes.
• Project management training and experience.

Culture & Benefits

• Learning and development-oriented culture.
• Annual performance-based bonus.
• Comprehensive benefits package including health insurance and 24/7 accident insurance.
• Flexible working hours.
• On-site restaurant providing healthy breakfast and lunch at exclusive company prices.
• Team-building activities, summer festivals, and free EV charging stations.