QA Manager
QA Manager.
QA Manager
Galway
|€80000 - €90000 per annum
|Permanent
|Quality Assurance/Quality Control
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.
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