Director of Operations – Quality

About the role

The Director of Operations – Quality leads all quality activities across manufacturing and supply‑chain operations for a medical‑device organization in Galway. This senior position combines strategic oversight with hands‑on leadership to ensure products meet regulatory and quality system standards in a fast‑growing environment.

Key responsibilities

• Lead quality functions at manufacturing sites, covering incoming inspection, in‑process controls, final release, and batch record review.
• Maintain governance over product release, batch record control, and implement statistical process control (SPC) to improve yield.
• Manage, mentor and develop the on‑site quality team, driving a strong culture of quality.
• Approve and control production quality procedures, work instructions, and QC sampling plans.
• Oversee deviations, non‑conformances, CAPAs and root‑cause investigations, ensuring timely closure.
• Ensure compliance with ISO 13485, MDR/MDD, 21 CFR Part 820 and support internal/external audits.
• Lead production‑related validations, equipment qualification and environmental controls.
• Drive supplier quality management, including audits, performance monitoring and corrective actions.
• Supervise cleanroom controls, sterilisation processes and quality aspects of facility expansions.
• Develop and report KPIs on product quality, scrap/rework, deviations and CAPA effectiveness to senior leadership.

Required profile

• Degree in life sciences, engineering or related discipline; advanced degree preferred.
• 8+ years of experience in medical‑device quality, with extensive hands‑on manufacturing exposure.
• Proven ability to lead and develop high‑performing quality teams.
• Strong knowledge of regulatory requirements and quality system standards.

Required skills

• ISO 13485
• MDR/MDD
• 21 CFR Part 820
• Statistical Process Control (SPC)
• Process validation
• Equipment qualification
• CAPA management
• Root‑cause investigation
• Supplier quality management
• Cleanroom control