Job Description
A key opportunity has arisen for a Quality Assurance expert to lead our Medical Devices team in Galway, Ireland.
The ideal candidate will oversee a Quality team supporting both manufacturing and new product development, ensuring compliance with ISO 13485, 21 CFR 820, and EU MDR while driving continuous improvement.
Key Responsibilities
* Oversee, develop, and support the Quality Engineering and Technician team to achieve departmental objectives.
* Provide technical input across manufacturing and new product introduction projects.
* Ensure effective operation and continual improvement of the QMS, including document control, calibration, internal audits, and CAPA/NCR processes.
Requirements
* Bachelor's degree in Engineering or Science.
* 5+ years' experience in Medical Device industry.
* 2+ years in a senior Quality role.
* Strong knowledge of QMS and regulations (ISO 13485, 21 CFR 820, MDR).
* Proven collaboration in regulated settings.
Benefits
This role offers a unique chance to drive quality excellence and contribute to the growth of our Medical Devices company.
Why this Role?
This is an exciting opportunity to work in a dynamic environment, leading a team that ensures the highest standards of quality in our products.