Quality Manager

3 weeks ago

Galway, Galway, Ireland Sterling Engineering Ltd - Ireland & Europe Full time

Job Title: Quality Manager

Location: Galway, Ireland

Industry: Medical Device / MedTech

Type: Full-time, Permanent

About the Role:

We are seeking a highly motivated and experienced Quality Manager to join a dynamic and growing medical device company based in Galway. This is a key leadership role responsible for overseeing all aspects of the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA regulations and applicable international standards.

The successful candidate will play a crucial role in supporting product development, sustaining engineering and manufacturing scale-up, while driving a strong culture of quality and continuous improvement across the organisation.

Key Responsibilities:

  • Lead the implementation, maintenance and improvement of the Quality Management System.
  • Ensure compliance with ISO 13485, FDA 21 CFR Part 820 and other relevant regulations and standards.
  • Manage internal and external audits, including notified body and regulatory inspections.
  • Oversee quality activities related to product development, design control, risk management and verification/validation.
  • Collaborate cross-functionally with R&D, Regulatory, Manufacturing and Supply Chain teams.
  • Lead and mentor the Quality team, promoting best practices and professional development.
  • Support supplier qualification, audits and incoming inspection processes.
  • Drive CAPA investigations, non-conformance handling and root cause analysis.
  • Maintain metrics and reporting on quality system performance product quality and improvement initiatives.

Requirements:

  • Bachelor's degree in Engineering, Science, or related discipline.
  • Minimum of 5 years' experience in Quality Assurance within the medical device or pharmaceutical industry.
  • In-depth knowledge of ISO 13485, FDA QSR and EU MDR.
  • Demonstrated leadership experience in managing and growing quality teams.
  • Strong understanding of risk management (ISO 14971) and design control processes.
  • Excellent communication, analytical, and organizational skills.
  • Experience working in a start-up or scale-up environment is a plus.

By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.

For more information and a confidential chat please contact Gerard Cunniffe on +353861908885

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