Senior Quality Engineer, Operations - Lead QA & Compliance

AMA Consulting Group LLC; Galway; On-site; EUR 60,000 - 80,000; Full time

Job summary

A medical device company in Galway is looking for a Senior Quality Engineer to lead quality efforts, mentor staff, and ensure compliance with FDA and ISO standards. The ideal candidate has extensive experience in the medical device industry, a Level 8 degree, and strong analytical and problem-solving skills. This role involves supporting the Quality Manager and driving continuous improvement initiatives.

Qualifications

• Minimum 5 years’ experience in a relevant role in the medical device industry.
• Clear understanding of medical device quality systems and requirements.
• Significant test method and process validation experience.

Responsibilities

• Support and mentor Quality engineers and technicians.
• Champion continuous improvement through CAPA system.
• Lead quality-focused projects ensuring timely completion.
• Ensure GMP standards and compliance in assigned area.
• Participate / lead Risk Analysis initiatives.

Skills

Problem-solving skills

Organizational skills

Communication skills (written and verbal)

Root cause analysis

Experience with FDA and ISO Quality systems

Knowledge of quality engineering

Education

Level 8 Degree in Science / Engineering or Quality Engineering

Job description

A medical device company in Galway is looking for a Senior Quality Engineer to lead quality efforts, mentor staff, and ensure compliance with FDA and ISO standards. The ideal candidate has extensive experience in the medical device industry, a Level 8 degree, and strong analytical and problem-solving skills. This role involves supporting the Quality Manager and driving continuous improvement initiatives.