Quality Engineer - Lean QMS, CAPA & Audits (Galway)

Collins McNicholas Group; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

Collins McNicholas Group in Galway is seeking a Quality Engineer for a Life Sciences company to drive quality across the QMS. The role focuses on implementing lean practices, reducing waste and improving efficiency within a regulated environment.

You will lead CAPA and non-conformance investigations, manage process and software validation, conduct internal audits, ensure regulatory compliance, support supplier management, and continuously develop the quality system in line with ISO standards.

Qualifications

• 3+ years' Quality Engineer experience in life sciences
• Knowledge of ISO 13485, ISO 14971 and ISO 14001
• Lean qualification/experience desirable
• Lead Auditor qualification required
• Excellent communication, problem-solving and attention to detail

Responsibilities

• Implement lean practices across the QMS
• Drive continuous improvement, reducing waste and increasing efficiency
• Lead problem-solving, CAPA and non-conformance investigations
• Manage process and software validation activities
• Conduct internal quality audits
• Ensure compliance with QMS and regulatory requirements
• Support and improve supplier management processes
• Develop and enhance the quality system in line with industry best practices

Skills

Organizational skills

Investigation skills

Communication skills

Problem-solving

Attention to detail

Education

Science or Engineering degree

Tools

CAPA systems

Job description

Collins McNicholas Group in Galway is seeking a Quality Engineer for a Life Sciences company to drive quality across the QMS. The role focuses on implementing lean practices, reducing waste and improving efficiency within a regulated environment.

You will lead CAPA and non-conformance investigations, manage process and software validation, conduct internal audits, ensure regulatory compliance, support supplier management, and continuously develop the quality system in line with ISO standards.