Quality Assurance Manager

In this role you lead the site’s quality management system and daily quality operations to ensure ISO 9001 compliance and superior product quality. You work hands-on on the shop floor, partnering with Production, Logistics, and Leadership to embed quality in daily operations. You act as the Quality System Management Representative and primary liaison for customers and external auditors, driving continuous improvement and risk management. This position offers scope to shape quality strategy, enhance efficiency, and support global quality objectives.

• flexible working hours
• competitive salaries
• learning opportunities and internships

• Direct the quality assurance function across departments to meet organizational goals
• Shape site QA program strategy and ensure regulatory compliance for processes, products, and markets
• Collaborate with Senior Leadership to deliver safety, quality, and process excellence while supporting growth
• Promote and embody Merit HEART program values in decision making
• Identify opportunities to improve systems, reduce cost, and enhance customer satisfaction
• Provide guidance on disposition of non-conforming products and initiate preventive actions
• Coordinate Emergency Management Team activities and oversee product investigations
• Oversee onboarding of new products/technologies and ensure smooth operations transitions
• Mentor and manage performance of QA staff; plan training and career development
• Provide technical support for existing products and new product transfers
• Maintain on-floor visibility to monitor processes and identify quality risks
• Prepare and review procedures and documentation for testing/manufacturing processes
• Lead verification and validation activities and support external inspections/audits
• Manage resources and projects within the QA team

• Bachelor’s degree in Quality Engineering/Engineering/Science or equivalent (NFQ Level 7+)
• At least nine years of related experience with minimum four years in a management role
• Proven track record in leading organizations through external inspections/audits (FDA, Notified Bodies, regulatory authorities, customers)
• Working knowledge of U.S. FDA, MDR EU 2017/745, ISO 13485, ISO 14971, CMDR, ANVISA, TGA, JPAL/JGMP
• Strong communication skills in English and local language
• Computer skills with standard office software and ability to learn specialized software
• Understanding of medical device industry and Merit’s product applications
• Postgraduate diploma/Master’s in Quality Management preferred
• Lean and Six-Sigma process-improvement aptitude preferred
• Experience in medical device manufacturing management preferred
• Proven leadership of large, international teams across regions preferred

• strong leadership and team management
• excellent communication and collaboration
• problem-solving and decision-making
• ISO 9001 Quality Management System
• FDA regulatory knowledge
• MDR EU 2017/745 understanding