Director of Operations Quality

About the role

The Director of Operations Quality will lead all quality activities across manufacturing and supply‑chain operations in our Galway facility. Reporting to senior leadership, you will combine strategic oversight with hands‑on involvement to ensure that every product, material and process complies with regulatory and quality system requirements in a fast‑growing medical‑device environment.

Key responsibilities

• Lead quality functions at manufacturing sites, including incoming inspection, in‑process controls, final release and batch record review.
• Maintain governance over product release, batch record control and statistical process control to improve yield.
• Manage, mentor and develop the on‑site operations quality team, driving a strong quality culture.
• Approve production quality procedures, work instructions and QC sampling plans; oversee deviations, non‑conformances, CAPAs and root‑cause investigations.
• Ensure compliance with ISO 13485, MDR/MDD, 21 CFR Part 820 and support internal/external audits.
• Oversee process and equipment validation, qualification and environmental controls, keeping documentation audit‑ready.
• Lead supplier quality activities, including selection, audits, performance monitoring and corrective actions.
• Control sterilization, cleanroom measures and facility expansion quality aspects.
• Develop and report KPIs on product quality, scrap, deviations and CAPA effectiveness to senior leadership.

Required profile

• Degree in life sciences, engineering or related field; advanced degree preferred.
• 8 + years experience in medical‑device quality with extensive hands‑on manufacturing exposure.
• Proven ability to lead and develop high‑performing quality teams.
• Strong analytical mindset and track record of driving continuous improvement.

Required skills

• ISO 13485
• MDR / MDD regulations
• 21 CFR Part 820
• Statistical Process Control (SPC)
• Process validation and equipment qualification
• CAPA management
• Root‑cause investigation
• QC sampling plan development
• Supplier quality management
• Cleanroom control
• KPI development and reporting