Quality Engineer

CREGG; Galway; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading Medical Device company in Galway is seeking a highly motivated Quality Engineer to ensure compliance with quality standards and drive continuous improvement. The role involves supporting new product development and conducting internal audits. Ideal candidates have a Bachelor's degree and at least 2 years of experience in quality engineering within regulated industries.

Qualifications

• 2+ years of experience in quality engineering, ideally in the medical device or regulated industry.
• Strong knowledge of FDA regulations and EU MDR.
• Detail-oriented and organized with a commitment to quality.

Responsibilities

• Ensure compliance with applicable regulations and quality management systems.
• Provide quality engineering support for new product development.
• Conduct internal audits and participate in risk management activities.

Skills

Quality engineering

Risk management

Statistical analysis

ISO 13485 compliance

Problem-solving

Education

Bachelor’s degree in Engineering, Science, or related discipline

Tools

CAPA

FMEAs

Validation tools

Job description

Quality Engineer - Galway

CREGG Recruitment are hiring for a Quality Engineer to join a leading Medical Device company in Galway.

For more information contact Mark: [emailprotected] or 0861901346

About the Role

We are seeking a highly motivated Quality Engineer to join our world-class medical device team in Galway. This is an exciting opportunity to contribute to the development and manufacture of life-changing products that improve patient outcomes worldwide. The successful candidate will play a key role in ensuring compliance with quality standards, driving continuous improvement, and supporting the delivery of safe, effective, and reliable medical devices.

Key Responsibilities

• Ensure compliance with applicable regulations (ISO 13485, FDA 21 CFR Part 820, MDR, etc.) and company quality management systems.
• Provide quality engineering support for new product development, manufacturing, and post-market activities.
• Participate in risk management activities, including FMEAs, hazard analysis, and control strategies.
• Drive root cause analysis and implement effective corrective and preventive actions (CAPA).
• Support validation and qualification activities (process, equipment, software, and test methods).
• Partner with cross-functional teams (R&D, Manufacturing, Regulatory, and Supply Chain) to ensure robust design transfer and product lifecycle management.
• Conduct internal audits and support external regulatory and notified body inspections.
• Identify opportunities for continuous improvement in processes, systems, and quality culture.

Qualifications & Experience

• Bachelor’s degree in Engineering, Science, or related discipline.
• 2+ years of experience in quality engineering, ideally in the medical device, pharmaceutical, or regulated industry.
• Strong knowledge of ISO 13485, FDA regulations, and EU MDR.
• Experience with risk management, validation, and statistical analysis tools.
• Demonstrated problem-solving skills with experience in CAPA, root cause analysis, and process improvement.
• Excellent communication and interpersonal skills, with the ability to work in cross-functional teams.
• Detail-oriented, organized, and self-driven with a commitment to quality and compliance.