QA Engineer
Hero Recruitment
Leitrim
QA Engineer. Our client a medical device company located in Leitrim requires a QA Engineerfor a permanent job on their team. Key responsibilities: Integration & Maintenance of the Quality Management System with all processes in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC. 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, MEDDEV93/42/EEC vigilance requirements and assisting inproductrecalls& 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. Education, Experience and Skills. 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. For further information on this QA Engineer role in Leitrim please contact Cliona O'Malley on 091730022 / cliona@hero.ie. Check out all our open jobs on our HERO Recruitment website - www.hero.ie. Please Note: HERO Recruitment will not forward your details to any company without your prior approval. This job originally appeared on RecruitIreland.com.
2505 days ago