Director of Quality Excellence

3 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €150,000 - €180,000

Quality Director Position

About the Role

We are seeking a seasoned Quality Director to join our executive team and drive quality excellence in our rapidly growing medical device start-up. As a strategic leader, you will develop and implement our Quality Management System (QMS), ensuring compliance with international regulations such as ISO 13485, FDA 21 CFR 820, and MDR.

Key Responsibilities:

  • Develop and execute the company's QMS, incorporating industry standards and best practices.
  • Collaborate closely with Operations, R&D, Regulatory Affairs, and Commercial teams to support product development, manufacturing, and market launch activities.
  • Build and scale quality systems to match the company's growth trajectory, including internal and external auditing, supplier quality management, and CAPA systems.
  • Mentor and develop a high-performing quality and regulatory team, fostering a culture of quality throughout the organization.
  • Provide strategic input on expansion initiatives and operational scale-up as part of the senior leadership team.
  • Serve as the main point of contact with regulatory bodies during inspections, audits, and certification processes.

Requirements:

  • Minimum of 10 years' experience in Quality Assurance within the medical device industry, with at least 3 years in a leadership role.
  • Demonstrated expertise in international medical device regulations and standards.
  • Proven ability to build, implement, and evolve scalable quality systems in a fast-paced environment.
  • Strategic thinker with strong leadership, communication, and team-building skills.
  • Experience supporting product commercialization and operational expansion is highly desirable.
  • Degree in Engineering, Science, or a related technical field; advanced degree preferred.

What We Offer:

  • A unique opportunity to shape the future of a high-potential medical device start-up.
  • A senior leadership role with influence across the entire organization.
  • Competitive compensation package, equity participation, and comprehensive benefits.
  • A collaborative, ambitious environment with a leadership team known for successful start-up growth and exits.

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