Quality Engineer

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

For more information contact Mark: [email protected] or 0861901346

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.

• INDTRAC