Impactful Quality Systems Engineer – Medical Devices

ProVerum Ltd.; Galway; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Visible impact

Long-term growth

Collaborative culture

Competitive package

Job summary

ProVerum Ltd. in Galway or Dublin is seeking a Quality Systems Engineer to join our Quality team onsite.

Reporting to the Quality Director, you will maintain and evolve the Quality Management System, support regulatory compliance, supplier quality, and audit readiness as we grow. You will lead quality processes and collaborate across the business to ensure compliant devices reach patients safely, contributing to CAPAs, change control, training, and supplier audits in a fast-paced medtech

Qualifications

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

Responsibilities

• Maintaining and continuously improving quality policies, procedures, change control, and training.
• Supporting complaint handling, CAPAs, and NCRs.
• Leading and supporting internal, supplier, and regulatory agency audits (FDA, Notified Body).
• Contributing to eQMS and ERP platform implementation projects.
• Developing quality plans and procedures to support commercialisation.

Skills

Hands-on

Communication

Proactive

Education

Bachelor’s degree in Engineering or Science

Job description

ProVerum Ltd. in Galway or Dublin is seeking a Quality Systems Engineer to join our Quality team onsite.

Reporting to the Quality Director, you will maintain and evolve the Quality Management System, support regulatory compliance, supplier quality, and audit readiness as we grow. You will lead quality processes and collaborate across the business to ensure compliant devices reach patients safely, contributing to CAPAs, change control, training, and supplier audits in a fast-paced medtech