Barrington James' QARA division are recruiting for a Director of Quality Assurance for an established Medical Device company based in Shannon, Ireland. This is a key leadership role in driving quality strategy and compliance for a diverse portfolio of advanced medical devices.

Key Responsibilities:

Lead and implement quality strategies aligned with global regulatory standards (QSR, FDA, ISO 13485). Oversee regulatory submissions and technical file management for EU, US, and RoW markets. Transition the Quality Management System from paper-based to digital. Mentor and manage a quality team, driving compliance and continuous improvement initiatives. Work cross-functionally to maintain and enhance quality and regulatory standards.

Qualifications:

10+ years in quality management in the medical device sector, including 5+ years in leadership roles. Strong expertise in ISO 13485, FDA QSR, and regulatory submissions. Certified Lead Auditor with experience in QMS implementation. Hands-on experience with Class II/IIb and III devices. Adaptable and collaborative, with a willingness to engage in both strategic and operational tasks.

This role is 5 days on site / 20% travel within the EU also required

 

If this sounds like your next opportunity, apply today or please email jsmith@barringtonjames.com !