Quality Engineer

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 & Experience

• Degree in Engineering, Science or related discipline
• Minimum of 2 years + experience working within Medical Device Manufacturing
• Experience working in a Manufacturing, Quality, or new product introduction role is desired
• Proven experience creating manufacturing Documents including; SOP's, change control, process risk documents
• Experience generating validation documents - IQ, OQ & PQ.
• The successful candidate must demonstrate strong time management and organisational skills.
• Excellent communication is essential.