Quality Engineer II - Validation & NPI (Onsite)

Medtronic; Athlone; On-site; EUR 50,000 - 75,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Competitive salary & benefits

Flexible benefits package

Job summary

Medtronic in Athlone, Ireland is seeking a Senior Quality Engineer to support process validation across the full product lifecycle, ensuring device performance and safety in line with regulatory requirements.

The role involves leading end-to-end validation activities, collaborating with cross-functional teams, and preparing qualification documentation. A strong background in quality systems and statistics is required, with onsite work in Athlone.

Qualifications

• Bachelor’s degree in Quality/Engineering/Science or related discipline.
• 3+ years experience in a medical devices or similar regulated environment.
• Knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies.
• Working knowledge of plastic processing techniques (Extrusion, Injection Moulding, Blow Moulding, Assembly) is an advantage.
• Practical knowledge of statistical data analysis and quality improvement tools is an advantage.

Responsibilities

• Provide Quality and Process Validation input to the new product introduction process.
• Oversee end-to-end validation activities to ensure regulatory, quality and business requirements are met.
• Collaborate with cross-functional teams and provide feedback on quality/validation requirements.
• Prepare, review, approve and execute qualification/validation documentation and perform statistical analysis.
• Provide online support during design/validation builds focusing on production control, evaluation and reliability.
• Contribute to product acceptance decisions and validation strategies within scope of responsibility.
• Complete test method validation for inspection/ testing methods and equipment.
• Ensure validation activities align with ISO 13485, FDA QSR, EU MDR and internal quality systems.

Skills

Bachelor’s degree

3+ years experience

Quality systems

Validation standards

Statistical analysis

Cross-functional teamwork

Initiative / multi-tasking

Education

Bachelor’s degree in Quality/Engineering/Science

Job description

Medtronic in Athlone, Ireland is seeking a Senior Quality Engineer to support process validation across the full product lifecycle, ensuring device performance and safety in line with regulatory requirements.

The role involves leading end-to-end validation activities, collaborating with cross-functional teams, and preparing qualification documentation. A strong background in quality systems and statistics is required, with onsite work in Athlone.