Design Quality Engineer

The Design Quality Engineer is responsible for implementing comprehensive process validation plans, ensuring compliance with regulatory and quality standards, and resolving complex quality issues. The role supports the design control process, from validating design inputs to managing verification, validation, and design transfer. The role reviews and refines quality engineering documents, initiates quality improvement projects, and provides expertise in risk management.

Requirements

• Bachelor's degree in Engineering
• Minimum 8 years of quality assurance experience
• Strong design control and new product development experience
• Strong analytical abilities
• Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP
• Strong communication, problem-solving, and continuous improvement skills
• Fluent in English both in writing and speaking