Quality Validation Engineer – Westmeath | Medical Devices | Permanent | On-site | €65,000
What you need to know
Our client in Westmeath is seeking a Quality Validation Engineer to join their team. Reporting to the Quality Manager, you will support and maintain the Quality Management System to ISO 13485 and ISO 14001 standards. This is a permanent, on-site, Monday–Friday daytime role.
Key Responsibilities (max 5)
* Maintain and implement the Quality Management System to ISO 13485, ISO 14001, and applicable medical device regulations.
* Conduct internal audits to ISO 13485 and support customer and regulatory audits.
* Participate in new product development, production trials, and quality investigations.
* Lead or support validation activities including generating and executing IQ/OQ/PQ protocols and reports.
* Manage non-conformances, CAPAs, deviations, and continuous improvement initiatives.
Requirements (max 5)
* Bachelor's degree in Engineering, Science, or related discipline.
* Minimum 3 years' experience in an ISO 13485-regulated environment.
* ISO 13485 Internal Auditor qualification.
* Strong experience in equipment validation, data/statistical analysis, and quality documentation.
* Excellent communication and problem-solving skills with ability to liaise across departments and with customers.
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