LSC have a great contract opportunity for a Validation Engineer to join a leading medical device company based in Limerick. The companies FDA regulated Limerick facility has grown consistently over the last 20 years to become one of the most important sites in its global operations. This facility specializes in the production of disposable contact lenses in a state-of-the-art operation which includes injection moulding, robotics, vision systems and sterilization systems in a Class 100,000 cleanroom environment.
If you have good knowledge of statistical techniques in the use of problem solving/ data analysis and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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
- Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
- Runs /Manages complaint investigation and resolution of same
- Designs and develops validation documentation to support business continuity, new process/product introductions and process improvement requirements
- Implementation and co-ordination of the change control process promotes timely approval of all supporting documentation
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A Bachelor's degree from accredited college
- 3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry.
- 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Ellen Farley at +353 214771329 if you have any more questions about this opportunity!
