Senior Design Transfer QA Engineer

Merit Medical Systems; Galway; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Salary package

Pension Plan

Health Insurance

Life Assurance

Wellbeing Events Calendar

Excellent career progression

Free Parking

Educational assistance

Internal training

Quality Subsidised Canteens & Barista

Active Sports and Social Club

Job summary

Merit Medical Galway seeks a Senior Quality Engineer to provide quality engineering support across product development and transfer activities. You will finalize requirements for design controls, risk management, and manufacturing compliance, ensuring conformity with 21 CFR 820 and ISO 13485, while guiding validation and testing strategies.

You will mentor teams, review nonconformances, and drive improvements, with a focus on maintaining robust quality documentation and supplier/audit readiness

Qualifications

• Bachelor's degree in Engineering or related field.
• 8+ years of engineering experience.
• Fluency in English and French.
• Knowledge of 21 CFR 820 and ISO 13485.
• Experience with Design Controls and risk management.
• Familiar with TMV, MVP, IQ/OQ/PQ.

Responsibilities

• Translate design requirements into manufacturing processes.
• Lead risk management activities and document results.
• Review, approve ECNs and test protocols for product lines.
• Mentor engineers and technicians on quality systems and compliance.
• Support internal and supplier audits and continuous improvement.

Skills

Design Controls

Risk Analysis

Quality Systems

Statistics

Project Management

TMV

MVP

IQ/OQ/PQ

Regulatory Knowledge

Education

Bachelor's Degree in Engineering

Tools

Minitab

JMP

Oracle

Job description

Merit Medical Galway seeks a Senior Quality Engineer to provide quality engineering support across product development and transfer activities. You will finalize requirements for design controls, risk management, and manufacturing compliance, ensuring conformity with 21 CFR 820 and ISO 13485, while guiding validation and testing strategies.

You will mentor teams, review nonconformances, and drive improvements, with a focus on maintaining robust quality documentation and supplier/audit readiness