Our client, a medical device organisation based in Galway, are seeking an experienced Lead QA/RA Engineer. This role will be responsible for the ongoing maintenance, audit, and continuous improvement of specific elements of the Quality Management System and participate in all regulatory activities including product certification and compliance.

The Role

This is a contract role and hybrid based, reporting to the Director of QA/RA.

Key Responsibilities would include:

• Responsible for measurement and analysis of Quality Objectives and Quality Projects.
• Responsible for the coordination and management of the QMS (including but not limited to Document Control, Audit process, NC/Deviations & CAPA, Product Hold, Complaints Management & Vigilance).
• Responsible for coordination of Design Assurance activities to support Design Control and Risk Management for new product and product changes.
• Support maintenance of technical files and DHFs and post-market activities.

The Person

In order to be considered for this exciting daily rate Lead QA/RA Engineer role, specific requirements for the successful candidate would include:

• Degree (L8) qualified in engineering, science, or a technical equivalent.
• Minimum of 5+ years relevant within the medical device sector in a relevant role.
• Significant quality/regulatory affairs experience including experience of EU/UK and US regulatory.
• In depth knowledge of product certification testing requirements for active Medical Devices.
• In depth knowledge of maintaining a certified Quality Management System under ISO 13485 and QSR/QMSR.

What's on offer:

• Exciting daily rate contract role within a start-up medical device company.
• Opportunity to work within a technical team giving you access to build your portfolio within the medical device industry.

To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 87 9383699 for a confidential discussion.