Quality Engineer II – Medical Devices & Process Improvement

integer; Galway; On-site; EUR 60,000 - 80,000; Full time

Job summary

Integer is seeking a Quality Engineer to apply general engineering methods with increasing use of advanced quality tools. You will work under guidance to resolve design and process problems and ensure adherence to quality management systems and regulatory requirements in a medical-device manufacturing context.

As part of the role, you will support regulatory inspections, document control, and continuous improvement initiatives while collaborating with cross-functional teams to deliver reliable

Responsibilities

• Lead generation and completion of test method validations protocols and reports.
• Review processes for new and existing products with manufacturing engineers.
• Coordinate process validations and capability studies.
• Develop inspection techniques to ensure product conformance to design specs.
• Support quality audits, CAPA activities, and plant investigations.

Skills

Quality engineering

Root cause analysis

Regulatory knowledge

Manufacturing experience

Tools

FMEA

Control Plans

CAPA

QMS

Job description

Integer is seeking a Quality Engineer to apply general engineering methods with increasing use of advanced quality tools. You will work under guidance to resolve design and process problems and ensure adherence to quality management systems and regulatory requirements in a medical-device manufacturing context.

As part of the role, you will support regulatory inspections, document control, and continuous improvement initiatives while collaborating with cross-functional teams to deliver reliable