Senior QA: Design Transfer & Validation Engineer

Merit Medical; Galway; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Salary package

Pension plan

Health insurance

Life assurance

Wellbeing events

Career progression

Recognition scheme

Free parking

Educational assistance

Internal training

Canteens & Barista

Job summary

Merit Medical is seeking a Quality Engineer to provide support for products and processes, ensuring compliance with design controls and risk management practices. The role includes leading risk analysis, coordinating ECNs, and guiding the design transfer to manufacturing.

The candidate should have a Bachelor's in Engineering with 8+ years of experience, fluency in English and French, and strong knowledge of medical device quality standards (21 CFR 820, ISO 13485).

Qualifications

• Bachelor's degree in Engineering or related field with 8+ years' experience.
• Fluent English and French language skills.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14791.
• Experience with TMV, MVP, IQ/OQ/PQ validations.
• Statistical methods, QC tools, lean, Six Sigma, project management.
• Proficient computer skills (spreadsheets, word processing, databases).

Responsibilities

• Provide quality engineering support for products and processes.
• Lead design control activities from inputs to outputs.
• Coordinate risk analysis/management and risk mitigation.
• Review and generate ECNs for verification, validation, and tests.
• Mentor engineers and technicians on quality system compliance.
• Support internal and supplier audits.

Skills

English fluency

French fluency

Quality systems knowledge

Statistical methods

Root cause analysis

Project management

TMV design

Education

Bachelor's Degree in Engineering

Tools

Minitab

JMP

Oracle

Job description

Merit Medical is seeking a Quality Engineer to provide support for products and processes, ensuring compliance with design controls and risk management practices. The role includes leading risk analysis, coordinating ECNs, and guiding the design transfer to manufacturing.

The candidate should have a Bachelor's in Engineering with 8+ years of experience, fluency in English and French, and strong knowledge of medical device quality standards (21 CFR 820, ISO 13485).