Quality Engineer, Medical Devices & Process Improvement

GxP Recruitment; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

GxP Recruitment is seeking a Quality Engineer for a large medical device client in Galway. The role involves supporting line moves, equipment updates, CAPAs and ensuring product quality with independent authority to disposition non-conforming product.

You will participate in customer complaints investigations and drive continuous improvements to product and process quality, with strong knowledge of QSR and ISO/MDD standards and regulatory requirements.

Qualifications

• Degree in engineering or science discipline is required.
• 2–4 years’ engineering level experience, preferably in medical devices.

Responsibilities

• Work on projects related to line moves, equipment updates, CAPAs and related quality tasks.
• Have the responsibility and authority to disposition non-conforming product.
• Participate in customer complaints investigations for areas under your control.
• Drive continual improvements in product and process quality.
• Be familiar with QSR and ISO/MDD standards and promote best industry practices.
• Conduct validation activities and regulatory compliance analysis as needed.
• Analyze data to establish specifications and performance standards for new or modified products/processes.
• Possibly participate in new product/technology transfers ensuring regulatory compliance.
• Guide Associate Quality Engineer, Technician and Inspection staff as needed.
• Interact with suppliers and other engineering disciplines as required.
• Be familiar with internal auditing processes.

Skills

Six Sigma

Statistical Analysis

Lean principles

Quality awareness

Education

Bachelor's degree in Engineering or Science

Job description

GxP Recruitment is seeking a Quality Engineer for a large medical device client in Galway. The role involves supporting line moves, equipment updates, CAPAs and ensuring product quality with independent authority to disposition non-conforming product.

You will participate in customer complaints investigations and drive continuous improvements to product and process quality, with strong knowledge of QSR and ISO/MDD standards and regulatory requirements.