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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Quality Manager


Reference:JCAO0205 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Manager, Quality Manager

Quality Manager – High-Growth Medical Device Start-Up – Galway

About the Company
Our client a rapidly growing, well-funded medical device start-up based in Galway, entering an exciting new phase of operational scale-up. With a high-potential product pipeline and a leadership team experienced in successful start-up growth and commercialization, are building out their core team to support ongoing manufacturing, development, and expansion activities.
The Opportunity
Client are seeking a hands-on and driven Quality Manager to take ownership of quality function. As they transition into a more operationally mature phase, this role will be central to ensuring robust, scalable quality systems are in place to support both internal manufacturing and our external supply chain.

Key Responsibilities

  • Maintain and evolve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR 820, and other applicable regulations.
  • Oversee all quality aspects of internal manufacturing operations, including batch release, in-process controls, and product inspections.
  • Provide quality oversight for subcontract manufacturing partners, including audits, quality agreements, and supplier performance management.
  • Lead internal and external audits, manage CAPAs, and ensure continuous improvement across all quality processes.
  • Support internal R&D, engineering, and operations teams with quality input during project development and tech transfer.
  • Act as the quality lead for product lifecycle activities from development through commercialization.
  • Work closely with regulatory affairs to ensure alignment across compliance and submission activities.
About You
  • 5+ years’ experience in quality assurance within the medical device industry, ideally with Class II/III devices.
  • Strong working knowledge of ISO 13485, FDA QSR, MDR, and relevant global regulatory frameworks.
  • Experience with both internal and contract manufacturing environments.
  • Demonstrated ability to build, maintain, and improve quality systems in a fast-paced setting.
  • Practical, solution-oriented approach with excellent communication and collaboration skills.
  • Degree in Engineering, Science, or a related technical field.
What’s on Offer
  • A high-impact role within a well-backed, innovation-driven start-up.
  • Opportunity to shape and lead the quality function during a critical phase of growth.
  • Competitive salary, benefits, and equity participation.
  • A dynamic and collaborative environment where your contributions directly influence company success.
If interested in discussing further please contact James Cassidy [email protected] or call in confidence 086 0203322