|Job Title:||Sterilisation Engineer|
|Job Published:||11 months ago|
Our client, a medical device company in Galway are currently looking to recruit a Sterilisation Engineer for their site.
? Provide expertise and leadership in the provision of validated sterilisation cycles to support the growing product portfolio (EO, radiation and other sterilisation technologies as applicable).
? Work closely with Production and Supply Chain to plan for optimal utilisation and provision of sterilisation capacity.
? Drive the execution of routine sterilisation load release in line with planned timelines.
? Resolve Quality issues in a timely manner in conjunction with all relevant stakeholders.
? Drive ongoing compliance to particulate, LAL, bioburden requirements with respect to product, work environment and ancillary services (RO water etc.).
? Liaise with laboratory service providers, interpret results of relevant microbiological and environmental testing, monitor and report on trends to management.
? Lead and contribute to continuous improvement activities as well as resolving relevant non-conformance and CAPA issues in conjunction with the wider QA, Operations, Supply Chain and R&D teams as appropriate.
? Provide guidance, direction and supervision to QA Technical staff as required.
? Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher); Post graduate diploma/Masters in Quality Management desirable.
? Knowledge and experience of regulatory compliance (FDA, ISO13485, CMDR, JPAL/JGMP) and relevant industry practices.
? Experience of applying Lean Six Sigma techniques to improve business processes & performance required.
? Four (4)+ years? experience in a similar role / environment
For further information on this Sterilisation Engineer role in Galway please contact Cliona O?Malley on 091730022 / email@example.com
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