Quality Engineer (12 month contract)

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

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