Validation Engineer required for a top medical device multinational in Limerick [initial 12 month contract]. The successful candidate will be involved with developing Validation documentation to support new process/product introductions and existing business continuity and process improvement requirements. You will also support the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations.
Role of this position
- 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.
- Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions.
- A Bachelor's degree from accredited college.
- 3-5 years in a Quality function.
- Experience within the Medical Device/ Pharmaceutical industry desirable but not essential.
- Ideally have a proven track record in development/execution of Validation programs in areas of Equipment and Process Information management.
- It would also be preferable for you to be 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.
Please contact Michelle Galvin today for further information on 091 373938 / mgalvinATcareerwise.ie
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