Medical Device Quality Assurance Role
We are seeking a highly motivated and detail-oriented individual to support the activities of Operations, Engineering, and Information Management in building product quality into our medical devices and ensuring compliance with pertinent regulations while maintaining operational effectiveness.
Key Responsibilities:
* Support the development and execution of validation activities associated with new equipment, products, or information management system upgrades.
* Investigate and resolve complaints in a timely manner.
* Design and develop validation documentation to support business continuity, new process/product introductions, and process improvement requirements.
* C coordinate the change control process to ensure timely approval of supporting documentation.
* Maintain awareness of and contribute to minimizing environmental and health & safety impacts of work performed.
Requirements:
* Demonstrated knowledge of relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices for global markets.
This is an excellent opportunity to join a leading multinational organization in Limerick, Ireland, and contribute to the development and delivery of high-quality medical devices.