Support the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations
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.
− 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 introductions
− Implementation and co-ordination of the change control process, promotes 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.
− Bachelors degree from accredited college
− 3/5 yrs in a Quality function within the Medical Device/ Pharmaceutical industry.
− Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
− Have a proven track record in development/execution of Validation programs in areas of Equipment
− Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, IS 13485) applicable to the manufacture of Class 111 medical devices to Global markets.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 7988480