Quality Director — Strategic Leader in Medical Devices

Harmonics Recruitment; Shannon; On-site; EUR 140,000 - 210,000; Full time

Job summary

Harmonics Recruitment seeks an experienced Quality Director in Shannon Co. Clare to provide strategic leadership for the quality function.

You will ensure the organisation meets regulatory requirements and quality objectives, while driving continuous improvement across all functions. The role requires extensive experience in medical device quality systems, strong communication skills and the ability to lead cross-functional teams.

Qualifications

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
• Minimum 15 years of quality management experience in medical device or FDA-regulated environment.
• Senior leadership experience (5–7 years).
• Lead Auditor certification and thorough knowledge of QSR/ISO requirements.

Responsibilities

• Develop and implement a comprehensive quality strategy aligned with long-term goals.
• Represent quality matters and ensure compliance with QSR, FDA, ISO and other regulations.
• Foster a culture of quality and continuous improvement across the organization.
• Lead quality improvement initiatives and projects.
• Oversee internal audits and ensure timely audits.
• Address non-conformances and escalate issues to senior leadership.
• Guide engineering, inspection and measurement processes.
• Lead problem-solving and corrective action teams.
• Review and approve CAPA actions and mentor the quality team.

Skills

Quality leadership

Regulatory awareness

Auditing & CAPA

Cross-functional leadership

Process improvement

Education

Bachelor's degree in a scientific or engineering discipline

Advanced degree preferred

Job description

Harmonics Recruitment seeks an experienced Quality Director in Shannon Co. Clare to provide strategic leadership for the quality function.

You will ensure the organisation meets regulatory requirements and quality objectives, while driving continuous improvement across all functions. The role requires extensive experience in medical device quality systems, strong communication skills and the ability to lead cross-functional teams.