Senior Quality Engineer, Medical Devices Validation Lead

IE7 COV - Mallinckrodt Medical; Athlone; On-site; EUR 65,000 - 97,000; Full time

Benefits offered by this job

Competitive salary

Flexible benefits

Incentive plan

Job summary

Medtronic is seeking a Senior Quality Engineer in Athlone, Ireland to lead end-to-end validation across the product lifecycle. You will collaborate with cross-functional teams, develop device validation strategy, and provide QE leadership to ensure ISO 13485, FDA QSR, EU MDR compliance while supporting audits and continuous improvement.

The role requires a minimum 8 Level bachelor’s degree in engineering or science and 5–7 years in Quality or Medical Devices with strong data analysis and

Qualifications

• Must have a minimum Level 8 bachelor’s degree in engineering or science with 5–7 years of experience in Quality or Medical Devices.
• Demonstrated expertise in IQ/OQ/PQ, risk management, and equipment and validation lifecycle management.
• Experience with statistical data analysis, problem solving and quality improvement tools.

Responsibilities

• Lead end-to-end validation activities to ensure processes, equipment, inspections and products meet regulatory, quality, and business requirements throughout the product lifecycle.
• Collaborate with cross-functional teams; develop strong partner relationships and provide quality leadership.
• Develop device process validation strategy and provide expert QE direction for equipment qualification and validation activities.
• Provide online support during design/validation builds focusing on production control, product evaluation, and reliability.
• Author and support qualification/validation plans and reports, performing statistical analysis to meet standards.

Skills

IQ/OQ/PQ

Statistical analysis

Problem solving

Quality engineering

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in engineering or science

Job description

Medtronic is seeking a Senior Quality Engineer in Athlone, Ireland to lead end-to-end validation across the product lifecycle. You will collaborate with cross-functional teams, develop device validation strategy, and provide QE leadership to ensure ISO 13485, FDA QSR, EU MDR compliance while supporting audits and continuous improvement.

The role requires a minimum 8 Level bachelor’s degree in engineering or science and 5–7 years in Quality or Medical Devices with strong data analysis and