Quality Assurance Engineer-Galway

ICDS Recruitment

Galway

QUALITY ASSURANCE ENGINEER (Sterilisation & Environment) - Galway. In this role you will: Provide expertise and leadership in the provision of validated sterilisation cycles to support the company's 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. Qualification/Experience 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. Minimum four years’ experience in a similar role / environment. Interested candidates should also have the following abilities/skills/qualities: Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media. Experience as both an auditor and an auditee for internal, supplier and 3rd party audits. Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to write clear and informative technical documentation, routine reports, correspondence, procedures and work flows. Present numerical data effectively. Possesses strong analytical skills and solution-driven thinking. Identifies and resolves problems in a timely manner; develops alternative solutions; works well in group problem solving situations; includes appropriate people in decision-making process. Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation. This job originally appeared on RecruitIreland.com.

2788 days ago