Quality Engineer

Role Overview

This opportunity is for a Quality Engineer to support a tightly controlled ISO 13485 setting in Athlone, Ireland. The position focuses on quality assurance, regulatory adherence, distribution quality oversight, and ongoing improvement across distribution and operational areas. The person in this role will help keep the quality system compliant, assist with investigations, and contribute to process enhancement work.

Key Responsibilities

• Assist with quality assurance systems, procedures, and controls covering medical devices and completed products.
• Evaluate, organize, coordinate, and roll out change controls while checking their quality and regulatory consequences.
• Partner with Manufacturing Engineering and Operations on risk reviews, process optimization, and quality-related projects.
• Take the lead or provide support in investigations linked to non-conformances, CAPAs, and issues affecting the quality system.
• Perform root cause analysis and put in place suitable corrective and preventive measures.
• Track quality performance patterns and use statistical methods to uncover areas for improvement.
• Support validation work, including strategy planning, sampling approaches, and execution for both new and existing product lines.
• Maintain compliance with ISO 13485, QMS requirements, and all relevant regulatory obligations.
• Spot possible quality and compliance risks and assist with actions to reduce them.
• Contribute to continuous improvement initiatives aimed at improving efficiency while preserving compliance.
• Work alongside Supply Chain, Operations, and Engineering teams to ensure strong quality governance.

Skills and Experience

The role requires a Bachelor’s degree in Engineering, Science, or a similar discipline, along with 3 to 5 years of experience in a regulated medical device environment. A solid understanding of ISO 13485 and Quality Management Systems is essential, as is hands-on exposure to change control, CAPA, and non-conformance handling. Familiarity with risk management methods such as FMEA, along with structured problem-solving and root cause analysis, is important. The ideal candidate should also be a confident communicator who can explain technical matters to both technical and non-technical audiences and be comfortable using Microsoft Office tools, including Excel, Word, and PowerPoint.

Additional Information

This position is based onsite in Athlone, Ireland. No additional compensation details, openings, or start-date information were provided.