Medical Device Quality Engineer (Contract) – ISO 13485

Freudenberg Medical; Carrick-on-Shannon; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Flexible Work Models

Health Insurance

Diversity & Inclusion

Personal Development

Company Pension

Job summary

Freudenberg Medical Ireland Ltd. in Carrick-on-Shannon, Co. Leitrim, is seeking a Quality Engineer on a fixed-term contract to ensure medical devices meet regulatory and customer requirements.

You will collaborate with Manufacturing and Engineering, support validation activities, CAPA and change control, and help maintain ISO 13485 and FDA-related quality processes while driving continuous improvement across the site.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• Experience with ISO 13485 and FDA requirements advantageous.
• Strong analytical and problem-solving skills; team player.

Responsibilities

• Support delivery of high-quality medical devices by collaborating with Manufacturing and Engineering to meet regulatory and customer requirements.
• Lead or support validation activities and maintain validation documentation and programmes.
• Investigate issues using structured problem solving to identify root causes and implement corrective actions.
• Assist in audits, CAPA, change control, and product release processes.
• Contribute to continuous improvement of quality systems and calibration programmes.

Skills

Quality Engineering

Validation Engineering

CAPA

Change Control

Regulatory Compliance

Problem Solving

Education

Bachelor’s degree in Engineering

Job description

Freudenberg Medical Ireland Ltd. in Carrick-on-Shannon, Co. Leitrim, is seeking a Quality Engineer on a fixed-term contract to ensure medical devices meet regulatory and customer requirements.

You will collaborate with Manufacturing and Engineering, support validation activities, CAPA and change control, and help maintain ISO 13485 and FDA-related quality processes while driving continuous improvement across the site.