Quality Systems Engineer

Staffline Rceruitment are hiring a Quality Systems Engineer based in Galway for a Medical Device organisation.

It is a full-time, permanent position on-site. This position will require an experienced Quality Systems Engineer to enhance and ensure compliance with their Quality Management System (QMS), aligning with US FDA QSMR and ISO 13485 standards.

This is an exceptional opportunity to take charge of a transformational project (expected duration: 18-24 months), in a well-established Quality team of seven engineers.

You will then transition into a key role managing and continuously improving the company's quality systems, focusing on maintaining ongoing compliance and operational excellence.

Key Responsibilities

• Spearhead the development and refinement of the company's QMS to meet FDA QSMR and ISO 13485 standards.
• Perform gap assessments to identify opportunities for improvement, implementing best-in-class practices.
• Develop, update, and revise quality procedures and documentation to comply with regulatory and operational requirements.
• Collaborate with cross-functional teams to facilitate the seamless adoption of new quality systems.
• Track and report on project progress, providing regular updates to senior management.
• Lead and assist with third-party audits, including FDA, ISO 13485, and Notified Body inspections.
• Drive continuous improvement efforts through root cause analysis and the implementation of CAPA (Corrective and Preventive Actions).
• Conduct internal audits to ensure alignment with ISO 13485 and Good Manufacturing Practices (GMP).
• Post-project, take ownership of managing quality systems, including document control, internal audits, and ensuring readiness for third-party audits.

Required Experience & Qualifications

• 4 years' experience minimum in a medical device manufacturing environment, specifically within a US FDA-compliant company.
• A Bachelor's degree in Engineering, Science, Quality Management, or a related field.
• Comprehensive understanding of ISO 13485 and US FDA QSMR regulatory requirements.
• Demonstrated experience in developing and writing quality procedures and documentation.
• Strong problem-solving skills with a background in root cause analysis and CAPA.

For more information please contact [email protected]