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 and FDA QSR (21 CFR Part 820) Assist with quality engineering activities across manufacturing and product development Participate in p FMEA, d FMEA, 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.
Benefits: Negotiable