Excellent opportunity for a Design Assurance and QA Specialist to join an innovative Medical Devices company in Galway. The successful candidate will support the R&D and QA teams with hands-on design assurance and quality systems compliance throughout the product development lifecycle. This role offers the chance to work in a fast-paced, collaborative environment on projects from early concept to commercialisation.
Overview of your responsibilities:
1. Identify and maintain compliance with all relevant medical device standards.
2. Prepare design assurance documents for global clinical studies and regulatory approvals.
3. Provide design assurance support across the full product development lifecycle.
4. Support design controls, change controls, non-conformance management, and QMS processes.
5. Ensure compliance with ISO 13485:2016, 21 CFR 820, and internal QMS requirements.
6. Monitor QMS performance, assist with audits, and contribute to Management Review.
7. Create technical plans and reports for internal and regulatory use.
8. Support audit readiness and close audit actions promptly.
9. Oversee Contract Manufacturer quality compliance and outsourced activities.
Knowledge, Skills and Experience Required for the Role:
10. Level 8 degree in a technical, scientific, or engineering discipline.
11. At least 3 years' experience in Design Assurance or a Quality role.
12. Hands-on experience working with ISO 13485, 21 CFR 820, or similar QMS.
13. Strong understanding of controlled product development and design controls.