Role: Senior Quality Systems Engineer Location:ATU Ihub - Galway Benefits: Top salary, hybrid working, bonus, pension and Shares Company: Brand new Medical Device start up with exciting new adventure. Role: Senior Quality Systems Engineer you will play a key role in the Set up, implementation and maintenance of the companys Quality Management System.This is a fantastic opportunity, which will allow you to work as part of a supportive, collaborative team in our state-of-the-art facility here in Galway. Responsibilities: Ensure the companies Quality Systems are compliant with, the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR 820 & 803, ISO 13485, ISO 14971. Maintenance and continuous improvement of the quality management systems. Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support the owners in meeting required timelines. Review & approval of Non-conformance, CAPA and Complaint investigation reports. Act as Coordinator for the Audit Management Process. Manage the annual audit schedule and coordinate internal and external audits as required. Track audit actions from initiation to closure. Coordinate activities in the preparation and management of audits by regulatory bodies. Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc. Education & Training Educated at a minimum to a Diploma Level in an Engineering, Science, or Quality Assurance discipline. Training/Qualification in Quality Systems, Complaints and CAPA is highly desirable. A minimum of five years relevent experience in the medical device industry. Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is required. Experience in management of Quality Systems activities, in particular Complaints and CAPA is desirable. To apply for more info call me on or email Benefits: Bonus, pension, healthcare, hybrid working