Galway Quality Engineer — Med Devices, CAPA & QMS Leader

Sigmar Recruitment; Athenry; On-site; EUR 55,000 - 75,000; Full time

Job summary

Sigmar Recruitment is recruiting a Quality Engineer for an established medical device manufacturer in Galway, Ireland. The role focuses on maintaining and improving the site’s Quality Management System (QMS) and driving quality initiatives across processes and suppliers.

You will lead investigations, CAPA activities, and validation efforts, ensuring compliance with ISO 13485, ISO 14971 and ISO 14001, while supporting product transfers and risk management. A Lead Auditor qualification is required.

Qualifications

• Degree or equivalent qualification in Science or Engineering.
• Minimum 3 years' experience as a Quality Engineer in a medical device or regulated manufacturing environment.
• Strong working knowledge of ISO 13485:2016, ISO 14971:2019 and ISO 14001.
• Lead Auditor qualification is required.
• Strong experience in quality investigations, problem-solving and CAPA processes.

Responsibilities

• Drive continuous improvement initiatives across the facility via Lean QM practices.
• Lead investigations, CAPA activities and corrective actions.
• Lead validation activities across manufacturing processes and software systems.
• Conduct internal audits and support external audits.
• Ensure compliance with quality management and regulatory requirements.
• Support supplier management and drive supplier quality improvements.
• Develop and enhance the Quality Management System per industry best practices.
• Provide Quality support for new product introductions and transfers.
• Support risk management activities and related quality processes.

Skills

Lead Auditor

CAPA

Problem solving

Regulatory compliance

Education

Science or Engineering degree

Job description

Sigmar Recruitment is recruiting a Quality Engineer for an established medical device manufacturer in Galway, Ireland. The role focuses on maintaining and improving the site’s Quality Management System (QMS) and driving quality initiatives across processes and suppliers.

You will lead investigations, CAPA activities, and validation efforts, ensuring compliance with ISO 13485, ISO 14971 and ISO 14001, while supporting product transfers and risk management. A Lead Auditor qualification is required.