Join a breakthrough Medical Device Company

Title: Quality Manager

Reporting To: COO

Industry: Life Sciences – Medical Devices – Early Stage

Salary: Up to €90,000 + bonus

Location: Ireland

Are you ready to shape the future of medical technology? An exciting opportunity awaits with a cutting-edge company revolutionising the treatment of Benign Prostatic Hyperplasia (BPH)-a condition affecting over half of men aged 50 and above. With a transformative, less-invasive device solution in development, this company is on a mission to deliver a better standard of care to patients around the world.

As they expand to meet growing demand and prepare for commercialization, they are seeking a Quality Manager to take the reins of quality operations and drive excellence across internal and external manufacturing.

What You’ll Do:

• Lead and evolve the company’s Quality Management System (QMS)
• Oversee internal manufacturing quality and external partners
• Champion supplier control, audits, SCARs, and performance monitoring
• Manage CAPAs, NCRs, complaints, and validation processes
• Take charge during regulatory audits (FDA, Notified Body)
• Inspire and guide a team of Quality Engineers & Technicians
• Provide hands-on QA support to Operations, aligning quality with business goals

What We’re Looking For:

• A degree in a scientific discipline and 4+ years in medical devices or pharma
• Solid grasp of ISO 13485 and 21 CFR 820
• A collaborative leader with excellent communication and team management skills
• Proven experience in quality systems, audits, and regulatory compliance
• A passion for innovation and the agility to thrive in a high-growth startup environment

Why Join?

• Be part of a game-changing technology that could help millions
• Work in an agile, fast-moving startup with global ambitions
• Enjoy meaningful work, real ownership, and a collaborative culture
• Grow your career in an expanding MedTech company poised for success

Please apply or email james.allen@darwinrecruitment.com for more information.

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

James Allen