QA Engineer- Leitrim
Collins Mcnicholas Recruitment
Leitrim
Our client, a leading Medical Device Company in Leitrim, is looking to hire a QA Engineer. Responsibilities: Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MDD 93/42/EEC. 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 MDD 93/42/EEC when appropriate. Completion of Validation Programme – Risk Analysis, VMP, IQ’s, OQ’s, PQ’s as required according to procedure QAP 030 and other related procedures. Integration & Maintenance of the Quality Management System with all processes 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. Vendor Assessment liaison & Maintenance. Requirements: Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical. Ideally 2-3 yrs previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment. For a confidential discussion, please contact Mark Whelan on 071 914 2411 or email mark.whelan@collinsmcnicholas.ie, For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos! This job originally appeared on RecruitIreland.com.
2348 days ago