Quality Systems Engineer – Medical Devices (Ireland)

ProVerum; Galway; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Visible impact from day one

Formative SME stage experience

Collaborative culture

Bonus potential

Job summary

ProVerum in Ireland is seeking a Quality Systems Engineer to join the Quality team in Galway or Dublin on-site. You will report to the Quality Director and help maintain and evolve the Quality Management System to support regulatory compliance and product development.

Key responsibilities include audits, CAPAs, change control, and coordinating with suppliers and regulatory bodies as we scale, commercialise and improve patient outcomes in a fast-moving medical device environment.

Qualifications

• Bachelor’s degree in Engineering or relevant Science field.
• Minimum 3 years’ experience in the medical device industry (or equivalent postgraduate study).
• Lead Auditor certification (preferred).
• Strong knowledge of ISO 13485 and FDA 21 CFR 820 (essential).

Responsibilities

• Maintain and continuously improve quality policies, procedures, change control, and training.
• Support complaint handling, CAPAs, and NCRs.
• Lead and support internal, supplier, and regulatory agency audits (FDA, Notified Body).
• Contribute to eQMS and ERP platform implementation projects.
• Develop quality plans and procedures to support commercialisation.

Skills

Hands-on

Communication

Teamwork

Education

Bachelor’s degree in Engineering or relevant Science field

Tools

eQMS

ERP platform

Job description

ProVerum in Ireland is seeking a Quality Systems Engineer to join the Quality team in Galway or Dublin on-site. You will report to the Quality Director and help maintain and evolve the Quality Management System to support regulatory compliance and product development.

Key responsibilities include audits, CAPAs, change control, and coordinating with suppliers and regulatory bodies as we scale, commercialise and improve patient outcomes in a fast-moving medical device environment.