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
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