15h Left: Quality Engineer

5 days ago

Galway, Ireland CREGG Full time

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.

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