Quality Systems Engineer - Medical Devices (Audit & Compliance)

Uniting Holding; Galway; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Company pension

Private health insurance

Job summary

ProVerum seeks a Quality Systems Engineer to maintain and evolve its Quality Management System in Galway or Dublin, reporting to the Quality Director. You will drive regulatory compliance, supplier quality, and audit readiness as the company scales its benign prostatic hyperplasia technology.

You will lead and support internal, supplier, and regulatory audits, contribute to eQMS/ERP projects, and develop quality plans to enable commercialisation while ensuring patient safety and product quality.

Qualifications

• Bachelor's degree in Engineering or a relevant Science field.
• Minimum 3 years’ experience in the medical device industry (or equivalent postgraduate study, Master’s / PhD).
• 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

Quality management

Auditing

Regulatory knowledge

Communication skills

Education

Engineering or science degree

Tools

ISO 13485

FDA 21 CFR 820

Job description

ProVerum seeks a Quality Systems Engineer to maintain and evolve its Quality Management System in Galway or Dublin, reporting to the Quality Director. You will drive regulatory compliance, supplier quality, and audit readiness as the company scales its benign prostatic hyperplasia technology.

You will lead and support internal, supplier, and regulatory audits, contribute to eQMS/ERP projects, and develop quality plans to enable commercialisation while ensuring patient safety and product quality.