Quality Engineer - Validation
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.Implement policies and procedures. 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 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. Qualifications and Experience: Bachelors degree in a relevant field. 2-4 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. Values/Innovations/Customer focus. Flexible. Team Player. Good Influencing Skills. Project Management Skills. Good generalist. Good communication skills. Methological. 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. Interested candidates should submit an updated CV. Please click the link below to apply, call Sean on 021 4297 900 or alternatively send an up to date CVsean.email@example.com. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.
74 days ago