Job Description: Quality Engineer (12-month contract)
We are hiring a Quality Engineer for a 12-month maternity cover contract based in Athlone. This role will focus on maintaining and improving the Quality Management System, ensuring regulatory compliance, and driving continuous improvement initiatives within a medical device environment.
Job Responsibilities
Lead CAPAs, non-conformances, and root cause investigations
Support and approve change controls and quality system updates
Drive process improvements using data and statistical tools (e.g. DOE)
Ensure compliance with manufacturing, packaging, and labeling standards
Lead internal and supplier audits and support external inspections (e.g. U.S. Food and Drug Administration, ISO 13485)
Act as a quality representative in cross-functional teams and site meetings
Job Requirements
Degree in Engineering, Science, or related field
5+ years’ experience in a regulated environment (medical devices preferred)
Strong knowledge of QMS and regulatory standards (e.g. ISO 13485, FDA)
Experience with CAPA, audits, and root cause analysis tools
Good understanding of statistical methods and risk management (e.g. FMEA)
Strong communication and stakeholder management skills
For more information or to apply, please contact: Brian Stack
Email: brian.stack@collinsmcnicholas.ie
Phone: 090 9703030
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