This global healthcare company is committed to improving the health and well being of people all over the world by developing, producing, and providing innovative healthcare services and solutions in more than 110 countries. With more than 80,000 employees globally, and over $40 billion in revenue per annum, this business operates in multiple divisions including Pharmaceuticals, Medical Devices and Diagnostics, primarily.

Within it's Diagnostics Division, there is significant investment at present, being undertaken in their operation in the West of Ireland. There is a growing quality operation being developed here due to legal transfer and global harmonisation projects. An opportunity has arisen for a Quality Engineer to join this dynamic team.

The Position

You will be responsible for supporting the establishment of the client as a legal manufacturer entity for select on-market and new products.

• Provide support to the implementation of the applicable quality system at Abbott Rapid Diagnostics Galway.
• Provide compliance oversight and guidance for design transfer activities for both entity & IVDR transfers and new products, as assigned.
• Provide compliance oversight and guidance for base business quality operations.
• Maintain awareness of applicable quality standards that regulate our industry. Maintain vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Support and/or lead the review and approval of quality system procedures and design records.
• Support and/or lead the development and update of associated Risk Management files.
• Ensure compliant documentation, carrying out tasks related to area of responsibility with management oversight.
• Support and/or lead product and process improvement activities from a quality perspective, ensuring supporting information/rationale for change including reasons and justifications is acceptable.
• Contribute to defining and timely achievement of overall design transfer project goals related to design control from transfer through product launch as assigned.
• Support and lead the development and implementation compliant solutions to problems/issues arising during design transfer/control activities, ensuring appropriate documentation of the event and subsequent resolution from a CAPA perspective.

The Person

• Bachelor's degree/master's degree in a science or technical discipline.
• Preferred experience in the healthcare sector.
• At least 3 year's work experience in a related field experience, less experience may be appropriate with advanced degree.
• Has a history of completing successful projects and driving positive compliance outcomes.

To discover more about this opportunity, apply now or contact Lewis Murray in HRM Search Partners on +353 872043307 for a confidential discussion.