Quality Engineer - Medical Devices (Flexible Work)

Freudenberg Medical; Connacht; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Flexible Work Models

Health Insurance

Diversity & Inclusion

Personal Development

Company Pension

Job summary

Freudenberg Medical Ireland Ltd. is seeking a Quality Engineer on a fixed-term contract to support delivery of high-quality medical devices. You will work with Manufacturing and Engineering to ensure regulatory and customer requirements are met.

The role involves validation, CAPA, change control, product release support, and participation in internal audits and supplier quality activities, applying ISO 13485 and FDA guidelines. A collaborative, hands-on approach is essential.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality or Manufacturing, ideally with a Medical Device emphasis.
• 2–3 years’ experience in a Quality or Validation Engineering role within a regulated manufacturing environment.
• Knowledge of ISO 13485 and FDA requirements; QMSR knowledge is an advantage.

Responsibilities

• Support delivery of high-quality medical devices with Manufacturing and Engineering to ensure regulatory and customer requirements are met.
• Play active role in new product introductions and change control to ensure proper implementation.
• Coordinate and support validation activities, including preparation, execution and maintenance of validation documentation.

Skills

Analytical skills

Problem solving

Cross-functional teamwork

Communication

Education

Engineering degree

Medical Device emphasis

Job description

Freudenberg Medical Ireland Ltd. is seeking a Quality Engineer on a fixed-term contract to support delivery of high-quality medical devices. You will work with Manufacturing and Engineering to ensure regulatory and customer requirements are met.

The role involves validation, CAPA, change control, product release support, and participation in internal audits and supplier quality activities, applying ISO 13485 and FDA guidelines. A collaborative, hands-on approach is essential.