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.
YOUR ROLE AT PROVERUM
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.
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
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
WHAT YOU WILL DO
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
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
*We are managing this search directly and do not require external recruitment support