Senior Medical Device Quality Assurance Specialist

1 week ago

Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €120,000
Quality Assurance Lead

Our company is seeking a highly skilled Quality Assurance Lead to join our team. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our products.

Key Responsibilities:
  • Maintain and evolve our Quality Management System (QMS) to ensure compliance with relevant 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.
Requirements:
  • 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 dynamic and collaborative environment.
  • Opportunity to shape and lead the quality function during a critical phase of growth.
  • Competitive salary, benefits, and equity participation.

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