Contract: Till the end of 2025

Location: Galway, Ireland

This project is focused on design and process validation, and it primarily involves bringing the project to completion.

As for the role, the client is looking for a Design Quality Engineer to join the team. The role will report into the Staff Quality Engineer and involves working closely with the project to ensure its successful completion. It is important to note that this is a catheter-based project, not a chemistry-based one. The position is critical to the final stages of the project, and there may be an opportunity for ongoing involvement following the project.

JOB RESPOSIBILITIES:

• Ensure compliance with Design Control and Risk Management activities and processes, managing and completing Quality deliverables for R&D projects.
• Provide Quality support and guidance to R&D project leads and team members, and direct Design Quality Engineers and Quality Engineers.
• Resolve project issues through collaboration with team members, suppliers, and other stakeholders, applying systematic problem-solving methodologies.
• Manage and maintain records related to design control projects, participate in design review meetings, and generate risk management file documents.
• Develop and review protocols and reports for sterilization, biocompatibility, and packaging validations, as well as review and approve R&D batch details and production records.
• Monitor data from Quality Management systems, provide immediate feedback on deviations or issues, and lead or facilitate compliance and improvement activities (e.g., CAPA/non-conformance).

Must Have

• 5 years of experience in a similar role
• Experience within Quality Assurance for medical devices in R&D including Validation, Design and Risk Management
• Experience in managing their own projects independently
• Independent and accountable, able to work on project, efficient communication
• Available to work from Galway, flexible to go on site for urgency

If this sounds exciting don't hesitate to apply today!