Senior Validation Engineer

Posted on Apr 17, 2019 by Anonymous

Limerick, Limerick Ireland
Health Care
Immediate Start
Annual Salary
Senior Validation Engineer

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.

Main Responsibilities:

* 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

Reference: 694542437

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