I am recruiting for a Quality Engineer on behalf of an innovative life science company based at their site near Dublin Airport.
Our client is involved in the development of pioneering medical devices and are currently going through an exciting period of development involving two new product introductions so as Quality Engineer you will get the opportunity to develop the future processes of the manufacturing site.
My client offers a very generous salary & benefits packages along with a defined path towards management for ambitious quality professionals looking to fast-track their career.
The position is based in state of the art facilities just a few kilometres from Dublin Airport and the site is well serviced by public transport.
As Quality Engineer some of the key elements of the role will include:
- QMS covering a broad range of activities including process change, risk assessment, CAPA, complaint handling, non-conformances, validation.
- Focus on and be responsible for process design improvements and updating quality system procedures to achieve both fully compliant and lean processes.
- Using lean tools, own and lead quality projects that deliver quality, cost and process improvements
- Identify potential weaknesses in the internal quality /control system and play a lead role developing and implementing the solutions on corrective action.
- Assess manufacturing's capability to meet quality requirements based on data analysis and internal audit.
- Support the process of generating pFMEA and work instruction documentation for internal manufacturing processes.
- Act as key liaison and knowledge transfer champion among Quality assurance, Manufacturing engineering, R&D, Document control in order achieve overall compliance.
As Quality Engineer you will hold a Degree in relevant scientific or engineering discipline and have an excellent understanding of Quality Assurance in a highly regulated industry. Experience of working to ISO 13485 and FDA 21 CFR Part 820 IVD and a background in product and process quality (including new product introduction) is highly advantageous for this role.
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