Senior Medical Device Quality Specialist

1 week ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €100,000

Key Quality Role for Medical Device Success

We are seeking an experienced quality professional to join our core team. This role will be central to ensuring robust, scalable quality systems are in place.

  • 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.

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