CREGG Recruitment are hiring for a Quality Engineer to join a leading Medical Device company in Cork.
For more information contact Mark: or
Key Responsibilities
Ensure compliance with applicable regulations (ISO *****, 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 *****, 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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