Quality Engineer-Medical Devices

1 week ago

Galway, Ireland Cregg Full time

Quality Engineer
roles available with Galway's world-leading medical device manufacturer.
For more information contact Rachel:
About the Role
Hours:
Mon-Friday 39hr week with a 1pm Friday finish
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.
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