Overview
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 *****, 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 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 ***** 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
Benefits:
Negotiable
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