Senior Validation Engineer
Posted on Apr 17, 2019 by Anonymous
Headcount Engineering is seeking a Senior Validation Engineer to join our team at a client's medical device facility in Limerick.
The Validation engineer will support the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations and will work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions.
* Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.
* Support 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
* Run /Manage complaint investigation and resolution of same
* Design and develop validation documentation to support business continuity, new process introductions
* Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
* Bachelor's degree in relative engineering discipline.
* 3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry.
* Good knowledge of statistical techniques in the use of problem solving/ data analysis.
* Proven track record in development/execution of Validation programs in areas of Equipment, Process Information management
* It is desirable to 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.
For further information, please contact Mick on (phone number removed) or forward details in confidence to