Director of Operations - Quality

Director of Operations Quality
Location: Galway (On‑site, Full Time)

Role Overview
The Director of Operations Quality is responsible for leading and overseeing all quality activities related to manufacturing and supply chain operations. This role provides strategic and hands‑on quality leadership, ensuring that production processes, materials, and products meet all applicable regulatory and quality system requirements. The position requires strong operational oversight, team leadership, and the ability to drive continuous improvement within a fast‑paced, growth‑oriented environment.

Key Responsibilities
Operational Quality Leadership

• Lead quality activities at manufacturing sites, including incoming inspection, in‑process controls, final release, and batch record review and disposition.
• Maintain governance over product release and batch record control.
• Implement and enforce in‑process controls and statistical process control (SPC) to improve yield and reduce variability.

Team Management

• Manage, mentor, and develop the on‑site operations quality team.
• Recruit, train, and build a high‑performing quality organization.
• Promote a strong culture of quality across manufacturing operations.

Quality Systems & Compliance

• Approve and control production quality procedures, work instructions, and QC sampling plans.
• Manage deviations, nonconformances, CAPAs, and root cause investigations; ensure timely closure and effectiveness checks.
• Ensure compliance with ISO 13485, MDR/MDD, 21 CFR Part 820, and other applicable regulations.
• Support internal and external audits related to manufacturing; lead responses to operations‑related findings.

Validation & Process Control

• Oversee production‑related validations and qualifications, including process validation, equipment qualification, and environmental controls.
• Ensure validation documentation is audit‑ready and compliant with regulatory expectations.
• Support process changes, scale‑up activities, capacity increases, and the transfer of new products or processes into production.

Supplier Quality

• Drive supplier quality management for production materials, including supplier selection, audits, performance monitoring, and corrective actions.
• Manage incoming quality agreements and ensure supplier‑related issues are addressed effectively.

Facility & Environmental Controls

• Oversee routine sterilization controls and lot release processes.
• Ensure cleanroom control measures are implemented and maintained.
• Lead quality aspects of facility expansion initiatives, ensuring quality requirements are integrated into new manufacturing layouts and workflows.

Performance Monitoring

• Develop and report KPIs related to product quality, scrap/rework, deviations, and CAPA effectiveness.
• Provide regular updates to senior leadership on operational quality performance.

Professional Qualifications & Attributes

• Degree in life sciences, engineering, or a related discipline; advanced degree preferred.
• 8 years of experience in medical device quality, with significant hands‑on manufacturing and supplier quality experience.
• Proven leadership experience managing quality teams.
• Strong knowledge of ISO 13485 and relevant regulatory requirements (MDR, 21 CFR Part 820).
• Demonstrated experience with production transfers, process validation, and manufacturing CAPA management.
• Proficient in SPC, FMEA, and root cause analysis tools (8D, Fishbone, 5 Whys).