This leading medical devices 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 device organisation remains one of the largest globally. Since its introduction to Ireland, this innovator has proceeded to continuously invest in the country, including investments in additional manufacturing and research sites across Ireland. One of the organisations primary plants based in South Dublin, is currently undergoing significant investment and change and has transformed it's 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 Supplier Quality Engineer to join it's expanding operation here in Dublin.
The Role
As Supplier Quality Engineer you will:
- Manage 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 the supplier audit schedule, and execute supplier audits as required.
- Contribute to OCP Supplier Management process, as appropriate.
- Provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820 Quality
- Ensure adherence to all BD and external regulatory requirements.
- 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.
- Support production personnel in relevant continuous improvement activities (Six Sigma etc.)
- Act as customer liaison contact for key customers as appropriate.
- Review, analyse and report on relevant customer complaints.
The Person
The successful candidate will have:
- Previous work experience in a Medical Devices OR Diagnostic organisation working to ISO 13485 standards with circa 3-5 years' experience.
- Hold a BSc in a Science or Engineering discipline.
To learn more about this role apply online or call Helena Boyle on + 353 1 6321870 or 0873360953 for a confidential discussion.
