Medical Device Quality Assurance Role
We’re currently recruiting for an exciting opportunity with a Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
1. Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness.
2. Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades.
3. Runs/Manages complaint investigation and resolution of same.
4. Designs and develops validation documentation to support business continuity, new process/product introductions and process improvement requirements.
5. Implementation and co-ordination of the change control process promotes timely approval of all supporting documentation.
6. All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
Education & Experience:
1. 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.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
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