Quality Engineer | Senior Quality Technician | Cork
An established medical device manufacturing organisation in Cork is seeking a Quality Engineer, with this role also well suited to an experienced Quality Technician looking to progress into a Quality Engineer position.
This is a hands-on role supporting quality engineering activities across manufacturing, cleanroom and laboratory environments, with strong exposure to ISO 13485, FDA QSR, CAPA, audits and risk management.
Key Responsibilities
- Support compliance with ISO 13485:2016 and FDA QSR (21 CFR Part 820)
- Assist with quality engineering activities across manufacturing and product development
- Participate in pFMEA, dFMEA, control plans and risk management activities
- Support CAPA, non-conformances and manufacturing deviations
- Assist with internal audits, investigations and root cause analysis
- Review Device History Records (DHRs) for accuracy and completeness
- Support validation, calibration and equipment maintenance activities
- Maintain controlled quality documentation in line with the QMS
Requirements
- Degree in Engineering or Science, or equivalent hands-on experience in a regulated medical device environment
- 3–5 years’ experience in medical device manufacturing, quality or laboratory roles
- Strong working knowledge of ISO 13485 and FDA Quality System Regulations
- Experience supporting audits, CAPA or non-conformance investigations
- Strong attention to detail with good documentation and communication skills
Apply now or contact Kerry Rickard for a confidential discussion.
