Quality Engineer - Validation
Independent Solutions
Limerick
Job Summary & Responsibilities Summary. 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. Responsibilities : Main areas of responsibility: - 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. Requirements Education and Experience Required for Role. Essential: - Bachelor’s 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, Process Information management. - Ability to demonstrate standards of leadership – Managing Complexity/Credo Values/Innovations/Customer focus. - Flexible. - Team Player. - Good Influencing Skills. - Project Management Skills. - Good generalist. - Good communication. Desirable : - 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. This job originally appeared on RecruitIreland.com.
2129 days ago