Quality Assurance Validation Engineer

Careerwise Recruitment

Leitrim

A Quality Assurance Validation Engineer is required by CareerWise Recruitment for our North-West based Medical Device manufacturing client. THE ROLE: * Integration & Maintenance of the Quality Management System with all the clients processes in accordance with the requirements of ISO 13485 & MEDDEV 93/42/EEC. * 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. * Vendor Assessment liaison & Maintenance. REQUIREMENTS: * Degree in Engineering/Manufacturing/Quality with emphasis on Medical Devices/Biomedical. * Ideally 2-3 years previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment. Please call Louise Mulligan today for further information on 094 900 3979 or email: lmulligan@careerwise.ie. CareerWise Recruitment - In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Mayo ,Cork, Shannon, Galway and Dublin. This job originally appeared on RecruitIreland.com.

2282 days ago