Exciting opportunity for a Senior / Principal Quality Engineer(level of seniority depending on experience)to join a medical device company developing and commercializing a platform interventional technology. A minimum of five years' experience in a similar role in the medical device or equivalent sector is required. You will support the development, maintenance and continuous improvement of the Quality Management System and will provide quality support to on-site manufacturing, product development and commercialization. You will report to the Quality & Regulatory Affairs Manager. This role offers hybrid (3 to 4 days on-site at the Selio Medical, Dublin facility) and flexible working hours.We are seeking a highly motivated self-starter who can work independently and drive projects forward on your own initiative.Role:Support the development and management of Selio Medical's Quality Management System to ensure compliance with ISO 13485, 21 CFR Part 820, 21 CFR Part 11 and MDR (as applicable).Manage all quality related activities for device manufacturing, for both product development and commercialization.Lead development of inspection plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and acceptance criteria and Process Validation activities.QMS process owner for Document/Record Controls, CAPA, Non-Conforming Product and Training.Leads Supplier Management and supplier evaluation process, including supplier audits.Participate in the risk management process in accordance with the requirements of ISO 14971:2019.Maintain and improve the Quality Manual, SOP's and work instructions.Lead internal audits to assess compliance to Standards and to the internal Quality System, including investigation, presentation of observations and findings, and reporting.Provide trending analysis on quality performance metrics and quality objectives.Lead Management Review meetingsProvide quality support for design and development activities (as required).Lead and manage the CAPA system.Support interactions with FDA, Notified Body, other agencies and vendors during company audits/inspections.Supports the preparation of technical files/submission packages and change packages to FDA / Notified Bodies and other regulators in applicable regions for new products.What you need:Proven experience with implementation, management and continuous improvement of a QMS in compliance with ISO 13485, 21 CFR Part 820, 21 CFR Part 11 and MDR (as applicable).Proven experience related to managing quality related activities for device manufacturing, for both product development and commercialization.Proven experience with design for manufacturing and design controls under quality management systems.Ability to effectively communicate and collaborate with all levels including management and representatives of various functional areas within the company.Proven experience on project management, problem solving, and change management skills.Ability to build positive working relationships, both internally and externally.This role requires a self- starter, who can see and deliver the work required to advance the company goals with a minimal amount of direction.Qualifications:Master's or Bachelor's degree (Life Sciences or Engineering).Minimum of 5 yrs experience in a Quality function, within an ISO 13485 QMS or equivalent.Benefits:Flexible working hours and opportunity to work from home.Bring a new medical device to market to benefit patients, clinicians and healthcare systems.Work with a passionate team in a fast-moving medical device start-up based in the Guinness Enterprise Centre, a connected innovation hub.Travel opportunities.Interaction with large medical device network.Fast tracked career progression.Excellent remuneration package.