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.
#J-18808-Ljbffr