Job Title: Quality Systems Engineer
**Overview:**
We are seeking a highly skilled Quality Systems Engineer to join our team at the centre of excellence for manufacturing in Dublin. This is an initial 2-year Fixed-Term Contract opportunity.
**Responsibilities:**
• Drive compliance with cGMP practices within Operations and Quality divisions
• Provide quality oversight to ensure compliance and promote quality improvements through consultation with other departments
• Ensure adherence to internal and external regulatory requirements
• Participate in internal audit teams and support external audits at the site
• Implement and maintain effective site processes, including Change Management, Internal Audits, and CAPA
• Prepare and present data on quality system performance to management
• Investigate and resolve CAPAs and Internal Audit findings, ensuring timely resolution and implementation of preventive actions
• Support process improvement activities and provide quality reviews of documentation, including procedures, specifications, investigations, GMP records, and other Quality Management System documents as required
**Requirements:**
• Degree in science or engineering
• Minimum 5 years' experience in a medical device or pharmaceutical regulated industry
• Experience working with established quality systems and leading CAPAs and internal audits
• Qualified internal auditor experience preferred
• Technical writing skills desirable