Quality 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 Engineer to join our Quality team in Galway or Dublin.

Reporting to the Quality Director, you'll play a central role in maintaining our QMS and provide product support across all stages. The ability to work in a flexible, small and entrepreneurial environment is essential.

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
• 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, reports and presentations
• Comfortable working in a fast-moving, small team environment where flexibility matters
• Strong project planning and organisational skills, with the ability to manage multiple priorities and deliver to deadlines

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

• Project support for implementation of platforms such as an eQMS and an ERP system
• Continuous improvement of the QMS (policies, procedures, change control, training) to support growth and regulatory compliance
• Support complaint handling, CAPAs, NCRs
• Development of quality plans, programs and procedures to support commercialisation, QMS activities, and product development
• Ensure that performance and product quality conform to company, customer and regulatory requirements
• Liaise and support OEM contractors/vendors during the manufacture of components and the assembly of devices for the purposes of design verification testing
• Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems
• Conduct supplier audits
• Support during internal audits
• Support during regulatory agency audits including FDA and Notified Body and aid in the preparation of non-conformity responses, as necessary

• 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