Role: Quality Systems Engineer
24 month ftc with strong chance of going permanent.
Based in Dun Laoghaire – on site role
Competitive salary, Healthcare, bonus or share options. Pension contribution from company after 24 months.


Job Purpose:

• Reporting to the Quality Systems Manager, duties will include implementing & maintaining the Company’s Quality Management System in accordance with applicable standards and regulations
• Responsibilities:
• Be a key driver of cGMP practices within Operations and Quality divisions
• Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements
• Ensure adherence to internal and external regulatory requirements
• Be an active member of the internal audit team and support external audits at the site
• Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA
• Prepare and present data to management on quality system performance
• Drive thorough investigation & root cause analysis of CAPAs and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence

• A minimum of 3 years work experience in the Medical Devices or Pharmaceutical regulated environment working within an established Quality System
• Proven experience leading CAPAs and Internal Audits
• Strong problem solving ability
• Experienced in technical writing and review with good attention to detail
• Qualified Internal Auditor experience