Senior Quality Engineer - Medical Devices Validation Lead

Medtronic; Athlone; On-site; EUR 65,000 - 97,000; Full time

Job summary

Medtronic in Athlone, Ireland, seeks a Senior Quality Engineer to lead device validation across the lifecycle, from development to post‑market support. You will provide technical direction on IQ/OQ/PQ, risk management, and validation lifecycle management within a regulated environment.

You will mentor engineers, work with cross‑functional teams, and contribute to continuous improvement of validation standards. The role emphasizes compliance with ISO 13485, FDA QSR, and EU MDR.

Qualifications

• Bachelor’s degree in engineering or science, level 8+.
• 5–7 years in Quality or Medical Devices preferred.
• Strong validation focus in IQ/OQ/PQ and risk management.
• Experience with statistical data analysis and problem solving.

Responsibilities

• Lead end‑to‑end validation activities for devices.
• Collaborate with cross‑functional teams to ensure quality.
• Develop validation strategy for processes and equipment.
• Support audits and regulatory compliance.

Skills

Quality engineering

Validation

IQ/OQ/PQ

Risk management

Statistical analysis

Problem solving

Cross‑functional collaboration

Documentation

Communication

Multi‑tasking

Education

Bachelor’s degree in engineering or science

Job description

Medtronic in Athlone, Ireland, seeks a Senior Quality Engineer to lead device validation across the lifecycle, from development to post‑market support. You will provide technical direction on IQ/OQ/PQ, risk management, and validation lifecycle management within a regulated environment.

You will mentor engineers, work with cross‑functional teams, and contribute to continuous improvement of validation standards. The role emphasizes compliance with ISO 13485, FDA QSR, and EU MDR.