QA Engineer
ICS Medical Devices
- Galway
- Permanent
- Full-time
As a Quality Engineer, you will support the maintenance and development of our Quality Management System, ensuring compliance with customer, regulatory, and internal requirements. You’ll work across the full product lifecycle—from concept through to production—contributing to high-quality outcomes across multiple production lines.This is a dynamic role where you’ll manage multiple projects, collaborate cross-functionally, and apply strong communication and problem-solving skills to drive quality excellence.Key ResponsibilitiesMaintain quality system metrics and support validation, production, and change control activitiesPartner with design and engineering teams on product development and design controlsSupport risk management, design assurance, and design verification & validation activitiesDevelop test methods, validation plans, protocols, and reportsContribute to design reviews and maintain Design History FilesSupport audits (internal, regulatory, and customer)Lead quality activities from incoming inspection to final product releaseProvide manufacturing support and quality expertise for product dispositionDrive continuous improvement and promote a strong quality cultureWork with suppliers to ensure compliance with quality standardsWhat We’re Looking ForDegree in Quality, Science, or Engineering4+ years’ experience in a medical device design or manufacturing environmentStrong knowledge of FDA & ISO 13485 quality systemsExperience with design assurance, validation, and manufacturing processesFamiliarity with statistical tools (e.g., Minitab) and Microsoft Office suiteExcellent communication and stakeholder management skillsDesirableExperience in new product introduction (NPI) and process transferKnowledge of medical device standards and regulatory requirementsIf you’re passionate about quality, innovation, and making an impact in the medical device industry, we’d love to hear from you.