Quality Engineer
Cork | Medical Device
My client, a global medical device company is currently seeking a Quality Engineer to join its growing team in Cork. This is a key role supporting quality activities across manufacturing and product development, focused on maintaining high standards and continuous improvement across the site.
Working as part of a small, hands-on team in Cork, you will report to the Site Lead and collaborate closely with a global Quality team. This is a permanent, full-time, on-site role working 39 hours per week, with half-day Fridays.
Key Responsibilities:
- Support compliance to ISO 13485, FDA QSR and internal quality standards
- Assist with product and process risk management (pFMEA, dFMEA, control plans)
- Participate in investigations, internal non-conformances, and CAPA activities
- Conduct Device History Record (DHR) reviews and support equipment calibration as needed
- Assist with internal audits and document control in line with global QMS requirements
- Contribute to the transfer, validation, and calibration of manufacturing processes
- Maintain compliance with health and safety standards including use of PPE in cleanroom/lab environments
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related field
- 3–5 years’ experience in a medical device manufacturing environment
- Working knowledge of ISO 13485:2016; familiarity with ISO 17025 and FDA QSR desirable
- Strong analytical, communication and organisational skills
- Proficiency in Microsoft Office (Word, Excel, Outlook)
Why Apply?
This is an excellent opportunity to work for an innovative and supportive organisation that values continuous improvement and professional development. The team in Cork is small and collaborative, with regular contact with global colleagues and access to training and development.
Interested? Apply now for an immediate interview or contact Kerry Rickard for more information