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 and continuous innovation, demonstrating the importance of this site to the organisations global manufacturing operations. At present, a requirement exists for a Quality Engineer to join it's expanding operation here in Dublin.
The Quality Engineer on this project/new product will be the key Quality Engineering representative and some of their responsibilities will include:
- Being a key driver of cGMP practices within Operations and Quality divisions
- Ensure design transfer activities are carried out
- Provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820 Quality Systems
- Become an active member of the site internal audit team, liaising with Regulatory auditors
- Prepare and maintain documentation in compliance with the appropriate regulatory requirements
- Support production personnel in relevant continuous improvement activities (Six Sigma etc.)
- Act as customer liaison contact for given key customers as appropriate
The successful candidate will have:
- A third level qualification in an Engineering or Science Discipline
- A minimum of 5 years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry
- Experience in the preparation of Technical Documentation
- Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous)
- Experience in CAPA system management
To learn more about this role apply online or call Helena Boyle on + 353 1 6321870 or 0873360953 for a confidential discussion.