Ref No: AM17676
County Dublin, Republic of Ireland
Supplier Quality Engineer - South Dublin.
In this position you will manage all quality related aspects of materials, and suppliers of those materials. This covers the management and, as required, the execution of supplier audits, incoming inspections, non-conformance investigations, supplier monitoring and communication. Related duties will include supplier process validation support, materials/ supplier change project management, process improvement projects.
Main responsibilities will include:
Support in leading all aspects of the Quality System with respect to supplier quality, including procedures, risk assessments and ASL.
Liaise with corporate supplier quality on projects, as required.
Maintain/ execute the Supplier Quality System Assessments (QSA) as per schedule.
Provide support for the ISO9001/ ISO13485 I 21 CFR Part 820 Quality Systems.
Become an active member of the site internal audit team.
Prepare and maintain supplier related documentation in compliance with the appropriate regulatory requirements.
Support projects to identify and qualify new/ alternative suppliers or materials.
Support production personnel in relevant continuous improvement activities (Six Sigma etc.).
Manage supplier related NOE/ QN, driving supplier investigations, responses, and effectiveness check.
Interested applicants should have:
A primary degree in a Science or Engineering discipline.
A minimum of 2 years' relevant work experience in an ISO 9001 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
Experience in the preparation of Technical Documentation.
Experience in CAPA system management.
Proven ability of working in a cross-functional team environment.
Excellent interpersonal and communication skills and high level of computer literacy.