This global medical device leading organisation has been a long time investor in Ireland with operations here since the 1960's. Employing in the region of 70,000 employees globally and with revenue north of 16 billion per annum, my client remains one of the largest and most advanced Medical Devices organisations worldwide. Since its introduction to Ireland, this innovator has proceeded to continuously invest and expand here with additional manufacturing and research sites across the country. One of the organisations' primary plants is based in South Dublin and is currently undergoing significant investment, growth and change. At present, a requirement exists for a Quality Engineer - Shift to join its expanding operation here in Dublin.
Reporting to the Quality Operations Leader, 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 successful candidate will have:
- Previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
- A degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
To learn more about this role apply online or call Helena Boyle on + 353 1 6321870 or 0873360953 for a confidential discussion.