What you need to knowOur client, an Irish-based medical device company who are currently seeking an experienced QA Engineer to join their organisation.This is a full-time position where you will be required to be on site in Co Leitrim.The QA Engineer will be reporting into the Senior QA Engineer and will work within part of a team.You new jobKey duties & responsibilities:Integration & Maintenance of the Quality Management System with all the clients' processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.Deputizing 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, MDD 93/42/EEC & MDR 2017/745.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 13485. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.Maintenance of the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/ preventive action programme.Participation in routine Failure Investigation & process troubleshooting.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 & 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.Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer.What you need to know?Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor's degree in a Science / Engineering / Quality related discipline.2-3 years' experience as Quality/Validation Engineer in Medical Device/Pharmaceutical EnvironmentAn Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.A Senior position may exist for a minimum of 6 years' experienceFully PC literate, use/knowledge of Minitab would be beneficialApply for this job now by sending in a Word version of your CV or get in touch with Ashley at or alternatively by phone at 087 113 7061.By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position.We Value Your Trust.
