Quality Engineer II - Medical Devices

We are looking for a Quality Engineer with at least 3 years of experience, including direct experience in in vitro fertilization (IVF), passionate about quality and innovation in medical devices, working in highly regulated environments with a focus on continuous process improvement.

Key Responsibilities:

• Manage CAPA, non-conformities, and change control
• Participate in internal and regulatory audits
• Perform process validations (IQ/OQ/PQ)
• Collaborate with multidisciplinary teams to ensure patient safety and product quality
• Maintain complete documentation in compliance with international standards

Mandatory Requirements:

• Bachelor’s degree in engineering, health sciences, or a related field
• Minimum 3 years of practical experience in quality, including IVF experience
• Knowledge of ISO 13485, MDR, MDSAP
• Functional English (reading, writing, and communication)
• Experience in validations and audits

What We Offer:

• Opportunity to grow in a high-tech, regulated environment
• Collaboration with multidisciplinary teams
• Continuous challenges in innovation and process improvement