QA CAPA/NCR Governance Engineer (Medical Devices)

Location: Castlebar, Mayo, Ireland

Company

hirify.global develops vital organ therapy solutions, including digital services and advanced solutions for kidney care and dialysis.

What you will do

• Complete and govern Non-Conformance Report (NCR) and CAPA records according to site procedures and quality standards.
• Track NCRs and CAPAs through closure while monitoring timelines and KPI targets.
• Conduct monthly NCR and exception trending analysis and report site Quality and QCR metrics.
• Perform adequacy reviews and escalate quality issues to the Corrective Review Board.
• Host Corrective Review Board meetings and weekly CAPA update boards.
• Provide subject-matter expertise, training, and guidance on NCR and CAPA processes while supporting continuous improvement.

Requirements

• Experience in the pharmaceutical, biotechnology, medical-device, or regulated manufacturing industry.
• Experience in a Quality Assurance or Quality Systems role.
• Strong communication, organisational, stakeholder management, analytical, and problem-solving skills.
• Excellent technical writing and documentation skills.
• Ability to work at the Castlebar, Mayo site in Ireland.

Culture & Benefits

• Competitive salary and annual bonus opportunity.
• Pension scheme, health and wellbeing programmes, life assurance, and income protection.
• Employee Assistance Programme and generous annual leave.
• Flexible working arrangements where appropriate for the role.
• Learning and development, internal career progression, and global mobility opportunities.
• Inclusive and collaborative working environment with recognition and reward programmes.