Quality Assurance Specialist
This is a full-time permanent role within a well-established Medical Device Manufacturing organisation in the heart of Galway city.
Key Responsibilities:
* Ensure alignment of the Quality Management System (QMS) with applicable regulations and standards through proactive compliance management.
* Conduct thorough gap assessments to identify areas for improvement and implement necessary actions to ensure regulatory expectations are met.
* Maintain an up-to-date audit schedule to guarantee seamless execution of internal and external audits.
* Coordinate all aspects of audits, from planning to follow-up, to ensure effective tracking and resolution of findings.
* Serve as the Coordinator for Corrective Action Preventive Action (CAPA) and Complaint processes, driving efficiency and effectiveness.
* Oversee software validation activities to maintain the electronic QMS in a validated state, ensuring data integrity and security.
* Analyse quality data to support monthly reporting and Management Review processes, providing valuable insights for informed decision-making.
* Monitor progress of quality system actions, escalating delays and supporting mitigation planning with senior stakeholders to drive timely resolutions.
* Promote continuous improvement of QMS processes across the organisation, fostering a culture of excellence.
* Act as a key quality liaison for cross-functional teams, ensuring compliance and promoting a quality-focused mindset.
* Coordinate the Temporary Authorisation process and related activities, streamlining operations and enhancing efficiency.
* Manage supplier quality processes, including selection, approval, monitoring, and performance reporting, to maintain high-quality partnerships.
The ideal candidate will possess excellent communication and organisational skills, with a strong attention to detail and ability to work effectively in a fast-paced environment.