-
Job Description
Medical Device Quality Assurance Role Summary: Responsible for ensuring product quality and regulatory compliance in a multinational organization.
We're currently recruiting for an exciting opportunity with a leading multinational organization based in Limerick. This is an excellent position for anyone looking to join a company that is one of the best at what they do.
Duties:
- Support the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to pertinent regulations while attaining operational effectiveness.
- Work with various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades.
- Run/Manage complaint investigation and resolution of same.
- Design and develop validation documentation to support business continuity, new process/product introductions and process improvement requirements.
- Implement and co-ordinate the change control process to promote timely approval of all supporting documentation.
- All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
Education & Experience:
- Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets.