QA Engineer

Description

My client has an immediate opening for a QA Engineer at their location in Co. Leitrim. This is an excellent opportunity to join a growing medical device company, who has become a leading extrusion and catheter provider to the medical device industry in Ireland

Requirements:
* Integration and maintenance of the Quality Management Systems with all processes in accordance with the requirements of ISO 13485 & Meddev 93/42EEC
* Deputising for the Management Representative in their absence
* Provision of support to all departments to ensure that products manufactured meet customer requirements.
* Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC.
* Review and Release of batch paperwork for Product release.
* Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845.
* Maintenance of the Customer Complaint investigation process, MEDDEV 93/42/EEC vigilance requirements and assisting in product recalls & corrective/ preventive action programme.
* Participation in routine Failure Investigation & process trouble-shooting
* Maintenance of plant Trending & Continuous process improvement programmes.
* Participation in the Plant Corrective Action Programme
* Participation in the Internal Quality Audit Programme
* Co-ordination & maintenance of the Calibration Programme
* Co-ordination & maintenance of the Validation Programme
* Maintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenance.
* Maintenance of the Plant Laundry & Rodent Control Sub-Contractors to required standards.
* Vendor Assessment liaison & Maintenance
* Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer.
* Quality System Certification, 2-3 years previous experience.

Our client currently going through an exciting growth phase and offers candidates an excellent opportunity to develop and progress their career.
If you feel that you would be a good fit for this role or know of someone who may be please apply directly or contact Derek Sheridan on for further information.

To find out more about Real please visit www.realstaffing.com