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 !