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:
- Identify and maintain compliance with all relevant medical device standards.
- Prepare design assurance documents for global clinical studies and regulatory approvals.
- Provide design assurance support across the full product development lifecycle.
- Support design controls, change controls, non-conformance management, and QMS processes.
- Ensure compliance with ISO 13485:2016, 21 CFR 820, and internal QMS requirements.
- Monitor QMS performance, assist with audits, and contribute to Management Review.
- Create technical plans and reports for internal and regulatory use.
- Support audit readiness and close audit actions promptly.
- Oversee Contract Manufacturer quality compliance and outsourced activities.
Knowledge, Skills and Experience Required for the Role:
- Level 8 degree in a technical, scientific, or engineering discipline.
- At least 3 years’ experience in Design Assurance or a Quality role.
- Hands-on experience working with ISO 13485, 21 CFR 820, or similar QMS.
- Strong understanding of controlled product development and design controls.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
