Medical Device Quality Lead

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €70,000 - €90,000

Quality Assurance Specialist

We are seeking a hands-on and driven Quality Manager to take ownership of quality function in a rapidly growing medical device start-up. The role will be central to ensuring robust, scalable quality systems are in place to support both internal manufacturing and our external supply chain.

  1. Maintain and evolve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR 820, and other applicable regulations.
  2. Oversee all quality aspects of internal manufacturing operations, including batch release, in-process controls, and product inspections.
  3. Provide quality oversight for subcontract manufacturing partners, including audits, quality agreements, and supplier performance management.
  4. Lead internal and external audits, manage CAPAs, and ensure continuous improvement across all quality processes.
  5. Support internal R&D, engineering, and operations teams with quality input during project development and tech transfer.
  6. Act as the quality lead for product lifecycle activities from development through commercialization.
  7. Work closely with regulatory affairs to ensure alignment across compliance and submission activities.

About You

  1. 5+ years' experience in quality assurance within the medical device industry, ideally with Class II/III devices.
  2. Strong working knowledge of ISO 13485, FDA QSR, MDR, and relevant global regulatory frameworks.
  3. Experience with both internal and contract manufacturing environments.
  4. Demonstrated ability to build, maintain, and improve quality systems in a fast-paced setting.
  5. Practical, solution-oriented approach with excellent communication and collaboration skills.
  6. Degree in Engineering, Science, or a related technical field.

What's on Offer

  1. A high-impact role within a well-backed innovation-driven start-up.
  2. Opportunity to shape and lead the quality function during a critical phase of growth.
  3. Competitive salary, benefits, and equity participation.
  4. A dynamic and collaborative environment where your contributions directly influence company success.

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