Quality Systems Specialist

Collins McNicholas Recruitment; Galway; On-site; EUR 35,000 - 45,000; Full time

Job summary

A medical devices company in Galway is looking for a Quality Systems Specialist to improve the Quality Management System and ensure compliance. This role is perfect for recent graduates, providing hands-on experience in quality processes within the medical device industry. Responsibilities include managing documentation, supporting audits, and implementing process improvements.

Qualifications

• 1+ year’s experience in a regulated or medical device environment.
• Good understanding of QMS principles and document control.
• Skilled in root cause analysis and problem-solving.

Responsibilities

• Maintain and manage QMS documentation to meet regulatory standards.
• Write and review SOPs to ensure compliance and clarity.
• Support internal audits, CAPA, and change control processes.
• Track and report quality metrics to site leadership.
• Identify and implement process improvements within the QMS.

Skills

Root cause analysis

Problem-solving

Communication

Time management

Organisation

Education

Degree in Science, Engineering, Quality, or related field

Tools

Microsoft Office

ERP systems

Job description

Excellent opportunity for a Quality Systems Specialist to join a Medical Devices company in Galway. The Quality Systems Specialist will maintain and improve the Quality Management System to ensure strong compliance, documentation control, and product quality. Ideal for a recent graduate looking to build a career in Quality Assurance within the medical device industry, with hands‑on exposure to key quality processes and cross‑functional teamwork.

Overview of your responsibilities

• Maintain and manage QMS documentation to meet regulatory standards.
• Write and review SOPs to ensure compliance and clarity.
• Support internal audits, CAPA, and change control processes.
• Track and report quality metrics to site leadership.
• Work cross-functionally to support QA activities and improvements.
• Identify and implement process improvements within the QMS.
• Ensure timely, accurate, and compliant QA documentation updates.

Knowledge, Skills and Experience Required for the Role

• Degree in Science, Engineering, Quality, or related field.
• 1+ year’s experience (including placement) in a regulated or medical device environment.
• Good understanding of QMS principles and document control.
• Skilled in root cause analysis and problem‑solving.
• Strong organisation, communication, and time management skills.
• Proficient in Microsoft Office and ERP systems.

For a confidential discussion and more information on the role contact Courtney Russell

[e-mail]

[phone]