Quality System Engineer

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

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

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