Director of Operations - Quality

Role Summary

We are seeking a Director of Operations Quality to oversee and direct all quality-related activities within manufacturing and supply chain operations at our Galway facility. The individual will be responsible for providing strategic quality leadership and hands-on management to ensure compliance with regulatory and quality standards, while fostering continuous improvement in a dynamic growth environment.

Core Responsibilities

• Lead quality oversight for manufacturing processes, including inspection of incoming materials, in-process and final release controls, and batch record review and approval.
• Maintain strict governance over product batch release controls and records management.
• Implement and monitor in-process controls and statistical process control methods to boost product yield and minimize variability.
• Manage and develop the on-site operations quality team through recruitment, mentoring, and training to build a strong quality culture.
• Oversee and approve production quality documentation such as procedures, work instructions, and QC sampling strategies.
• Handle deviations, nonconformances, corrective and preventive actions (CAPAs), and root cause analyses with prompt closure and effectiveness checks.
• Ensure regulatory compliance with standards such as ISO 13485, MDR/MDD, 21 CFR Part 820, and other relevant frameworks.
• Lead support for internal and external audits related to manufacturing and coordinate responses to findings.
• Supervise validation processes, including process validations, equipment qualifications, and environmental controls to maintain audit-ready documentation.
• Support scale-up activities, process changes, and new product or process transfers into production.
• Drive supplier quality management by selecting suppliers, performing audits, monitoring performance, and managing supplier-related corrective actions.
• Oversee quality controls in sterilization, lot release, and cleanroom environment maintenance.
• Lead quality requirements integration in facility expansion projects, ensuring new manufacturing layouts comply with quality standards.
• Develop key performance indicators (KPIs) for product quality, scrap/rework rates, deviations, and CAPA effectiveness, providing senior leadership with regular performance updates.

Qualifications and Skills

• Bachelor’s degree in life sciences, engineering, or a related field; an advanced degree is preferred.
• A minimum of eight years’ experience in medical device quality, particularly with manufacturing and supplier quality management.
• Proven leadership capabilities in managing quality teams.
• Comprehensive knowledge of ISO 13485, MDR, 21 CFR Part 820, and medical device regulatory standards.
• Experienced in production transfers, process validation, and manufacturing CAPA handling.
• Skilled in statistical process control (SPC), failure mode and effects analysis (FMEA), and root cause analysis techniques such as 8D, Fishbone diagrams, and the 5 Whys.