6-12 month hourly contract opportunity for a Quality Engineer looking to join a leading global Cork based Medical Device organisation.Key Responsibilities:Support DMR remediation: Assist with any tasks necessary to ensure the completion of Design Manufacturing Records (DMR) remediation projects within the specified timeframes.Manage validation and characterisation documents: Draft and approve validation protocols and Process Characterisation reports.Process and equipment documentation: Write, review, and approve Repeat Action Assessments (RAA) and Acceptance Equipment Lists (AELs).Update manufacturing instructions: Review, revise, and approve Manufacturing Instructions (SGOIs) and Manufacturing Execution System (MES) documents.Oversee corrective actions: Take ownership of non-conformance (NCEP) and corrective and preventive action (CAPA) plans related to DMR remediation.Skills, Attributes & ExperienceDegree in Engineering, Science or related disciplineMinimum of 2 years + experience working within Medical Device ManufacturingExperience working in a Manufacturing, Quality, or new product introduction role is desiredProven experience creating manufacturing Documents including; SOP's, change control, process risk documentsExperience generating validation documents - IQ, OQ & PQ.The successful candidate must demonstrate strong time management and organisational skills.Excellent communication is essential.
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