Medical Device Quality Assurance Role
We are currently recruiting for an exciting opportunity with a Medical Device organization based in Limerick. This is an excellent position for anyone looking to join a leading multinational company that excels in its field.
Duties:
* Support the activities of Operations, Engineering, and Information Management in building product quality into our products and ensuring compliance with pertinent regulations while maintaining operational effectiveness.
* Work with various departments/groups in developing and executing validation activities associated with new equipment/product or I.M. system upgrades.
* Manage complaint investigation and resolution.
* Design and develop validation documentation to support business continuity, new process/product introductions, and process improvement requirements.
* Implement and coordinate the change control process to ensure timely approval of all supporting documentation.
* All employees are responsible for minimizing both environmental and health & safety effects of the work they perform.
Education & Experience:
* Familiarity with relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices for global markets.
Requirements:
* Knowledge of quality assurance principles and practices.
* Understanding of regulatory requirements and industry standards.
* Excellent communication and interpersonal skills.
* Ability to work independently and as part of a team.
* Strong problem-solving and analytical skills.