This leading medical device organisation has been a long time investor here in Ireland with operations in Ireland since the 1960's. Employing in the region of 70,000 employees globally and revenues north of 16 billion per annum, this medical devices organisation remains one of the largest global Medical Devices organisations globally. Since its introduction to Ireland, this innovator has proceeded to continuously invest in this country including investments in additional manufacturing and research sites across Ireland. One of the organisations' primary plants based in Leinster is currently undergoing significant investment and change. It has transformed its operations in Ireland through strong leadership, continuous innovation and demonstrating the importance of this site to the organisations global manufacturing operations. At present, a requirement exists for a Quality Engineer - Shift to join its expanding operation here in Dublin

The Role

In this role you will be responsible for:

• Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements
• Driving root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue
• Driving and maintaining cGMP practices across all operational departments under your quality responsibility (Incoming, moulding, assembly, packaging sterilisation, warehouse) and attend departmental and other meetings as appropriate
• Preparation of relevant work sheets and execution of final inspection tests and line clearance verification
• Releasing batches in SAP from packaging to sterilisation and final release & Complete DHR reviews and batch releases
• Completing Product Quality Testing & Validating test methods
• Ensuring that maintenance records and process adjustments records are maintained and captured in real time
• Liaising with relevant personnel regarding flow of product through QC department and other issues that arise
• Reviewing, analysing and reporting on relevant customer complaints and institute corrective actions

The Person

The successful candidate will possess:

• Previous work experience in a medical devices OR diagnostic organisation previously working to ISO 13485 standards with circa 2-3 years' experience in this industry
• A degree in a Science/Engineering discipline

To learn more about this role apply online or call Helena Boyle on + 353 1 6321870 for a confidential discussion.