Quality Engineer

4 weeks 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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