Quality Systems Engineer

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

Quality Systems Engineer

Location: Galway or Dublin, Ireland | Full-Time, On-site | Reports to: Quality Director

ProVerum is changing how Benign Prostatic Hyperplasia (BPH) is treated, pioneering minimally invasive technology that sets a new standard of care. As we scale, we're looking for a Quality Systems Engineer to join our Quality team in Galway or Dublin.

YOUR ROLE AT PROVERUM

Reporting to the Quality Director, you’ll play a central role in maintaining and evolving our Quality Management System, supporting regulatory compliance, supplier quality, and audit readiness as we grow, commercialise and improve patients’ lives.

WHAT YOU WILL NEED

Qualifications & Experience

• 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)

Skills & Approach

• Hands-on, motivated, and proactive, you take initiative and follow through
• Strong written and verbal communication skills; confident producing procedures, plans, and reports
• Comfortable working in a fast-moving, small team environment where flexibility matters
• 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
• Visible impact from day one: your work directly supports the devices that reach patients
• Build something lasting: join at a formative stage and develop deep SME-level expertise
• Collaborative culture: work with people who care deeply about quality and patient outcomes
• Competitive package: market salary, bonus potential, company pension, private health insurance and more

WHAT YOU WILL DO

You’ll support the full breadth of our QMS activities, including:

• 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

WHAT WE OFFER

• Visible impact from day one: your work directly supports the devices that reach patients
• Build something lasting: join at a formative stage and develop deep SME-level expertise
• Collaborative culture: work with people who care deeply about quality and patient outcomes
• Competitive package: market salary, bonus potential, company pension, private health insurance and more