Senior Quality Engineer: Process Validation

IE7 COV - Mallinckrodt Medical; Athlone; On-site; EUR 50,000 - 75,000; Full time

Job summary

Medtronic in Athlone is seeking a Senior Quality Engineer to provide QA and process validation input across the product lifecycle. You’ll oversee end-to-end validation activities and collaborate with cross-functional teams to ensure regulatory and quality standards are met.

The role supports new product introductions and maintenance of device safety and performance. The ideal candidate has a minimum 3+ years in medical devices, knowledge of ISO 13485, FDA QSR, and EU MDR, and practical

Qualifications

• Minimum Level 8 bachelor’s degree in Quality/Engineering/Science.
• 3+ years in medical devices or regulated environment.
• Knowledge of ISO 13485, FDA QSR, EU MDR.
• Experience with validation and quality control tools.

Responsibilities

• Provide QA and Process Validation input to the new product introduction process.
• Oversee end-to-end validation activities to ensure processes, equipment, inspections and products meet regulatory, quality, and business requirements.
• Collaborate with cross-functional teams and provide constructive feedback on quality/validation requirements.
• Author/review/approve/execute qualification/validation documents and perform statistical analysis.
• Provide on-going support during design and/or validation builds with focus on production control and reliability.

Skills

Quality Systems

Validation standards

Statistical analysis

Cross-functional teamwork

Communication skills

Education

Bachelor's degree (Level 8)

Tools

Minitab

Statistics software

Job description

Medtronic in Athlone is seeking a Senior Quality Engineer to provide QA and process validation input across the product lifecycle. You’ll oversee end-to-end validation activities and collaborate with cross-functional teams to ensure regulatory and quality standards are met.

The role supports new product introductions and maintenance of device safety and performance. The ideal candidate has a minimum 3+ years in medical devices, knowledge of ISO 13485, FDA QSR, and EU MDR, and practical