Medical Device Quality Assurance Role
We are currently recruiting for an exciting opportunity with a leading multinational based in Limerick. This is an excellent position for anyone looking to work with one of the best companies in the industry.
Duties:
* Support the activities of Operations, Engineering, and Information Management to build product quality into our products and ensure compliance with pertinent regulations while achieving operational effectiveness.
* Collaborate with various departments to develop and execute validation activities associated with new equipment, products, or system upgrades.
* Investigate and resolve complaints.
* Design and develop validation documentation to support business continuity, process introductions, and improvement requirements.
* Implement and coordinate the change control process to ensure timely approval of supporting documentation.
* All employees are responsible for minimizing environmental and health & safety impacts related to their work.
Education and Experience:
* Familiarity with relevant regulatory standards (FDA - Quality System Regulations, ISO 13485) applicable to Class III medical devices in global markets.