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 Device 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.
