Quality Director (Medical Devices)

Location: Spiddal, County Galway, Ireland

Company

hirify.global operates in medical device manufacturing and quality-regulated production.

What you will do

• Provide strategic leadership for Quality and Regulatory Management and align quality strategies with wider business objectives.
• Implement and maintain an effective quality management system compliant with ISO 13485, FDA requirements, hirify.global standards, and other applicable regulations.
• Develop quality operating plans, metrics, budgets, management reviews, and continuous improvement initiatives.
• Lead the quality function through new product and process introductions, partnering with customers and manufacturing teams.
• Manage supplier quality assurance, resolve quality issues with suppliers and customers, and ensure compliance with agreed specifications.
• Build Quality team capabilities, support professional development, and educate staff on quality systems and regulatory responsibilities.

Requirements

• Bachelor’s degree in Science, Engineering, Manufacturing, or a related field.
• At least 10 years of relevant progressive experience in a similar environment, including 5 or more successful years in a leadership position.
• Thorough knowledge of medical device quality systems and regulatory requirements, including ISO 13485 and FDA standards.
• Experience using SAP ERP and proficiency in Microsoft Office Suite.
• Ability to achieve goals through collaboration, influence, and interaction across all business levels.

Nice to have

• Knowledge of Lean and Six Sigma methodologies.

Culture & Benefits

• Full-time employment.
• Equal opportunity workplace committed to diversity and inclusion.
• Responsibility for health, safety, and environmental compliance alongside quality and regulatory objectives.