QA Engineer
CPL
Leitrim
A medical device company in the West of Ireland is looking for QA Engineer. Responsibilites: This involves but is not limited to: Integration & Maintenance of the Quality Management System with all VISTAMEDprocesses in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC. 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. Generation of Product Technical Files & associated studies in accordance with MEDDEV 93/42/EEC when appropriate. 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. Criteria: Third level qualification in Engineering/Manufacturing/Quality with emphasis on Medical Device/Biomedical. 2-3 years’ experience as Quality/Validation Engineer in Medical Device/Pharmaceutical Environment. Fully PC literate, use/knowledge of Minitab would be beneficial. Interested candidates please contact Rebecca Meaney on +35391507509 or email your CV to rebecca.meaney@cpl.ie. This job originally appeared on RecruitIreland.com.
2440 days ago