Lead Design Quality Engineer - MedTech (Galway)

jj; Galway; Hybrid; EUR 63,000 - 101,000; Full time

Job summary

Johnson & Johnson in Galway, Ireland, is seeking a Lead Design Quality Engineer to join our MedTech Neurovascular team. You will provide design quality expertise to support new product development, design changes, and lifecycle management, collaborating with R&D, Regulatory Affairs, Manufacturing, and other functions to ensure compliance.

This role leads Design Control, Risk Management, and Quality System activities, guiding teams through development from concept to launch and post-launch.

Qualifications

• Degree in Engineering, Science, or related technical field.
• Minimum 6 years in the medical device, IVD, pharmaceutical, or regulated industry.
• Minimum 3 years leading Quality Management System processes or sub-processes.

Responsibilities

• Lead Design Control and Risk Management across development and lifecycle.
• Guide product development with R&D and regulatory teams.
• Support design transfer, validation, and launch planning.
• Ensure compliance with 21 CFR Part 820 and ISO 13485.

Skills

Project management

Analytical thinking

Communication

Problem solving

Leadership

Cross-functional collaboration

Education

Engineering/Science degree

Job description

Johnson & Johnson in Galway, Ireland, is seeking a Lead Design Quality Engineer to join our MedTech Neurovascular team. You will provide design quality expertise to support new product development, design changes, and lifecycle management, collaborating with R&D, Regulatory Affairs, Manufacturing, and other functions to ensure compliance.

This role leads Design Control, Risk Management, and Quality System activities, guiding teams through development from concept to launch and post-launch.