Quality Engineer

Quality Engineer

REPORTING TO: Quality Manager

This role would be onsite based in Shannon

JOB PURPOSE: Develop, establish and maintain quality systems and practices which meet the company, customer and regulatory requirements.

PRINCIPAL ACCOUNTABILITIES:

• Ensure compliance with all pertinent regulations (e.g. FDA, ISO)
• Ensure compliance and execute activities to the QMS such as non-conformance investigations, CAPA, Change control, complaints, document control, and record retention.
• Support DHR reviews to ensure timely release of product
• Develop, implement and maintain procedures and forms.
• Support production activities in building quality into products and assuring compliance to the pertinent regulations
• Lead and execute upgrades to the quality system
• Participation, co-ordination and maintenance of the audit system.
• Support customer and regulatory audits
• Ensuring the promotion of the awareness of customer requirements in the company.
• Producing daily management reports with a view to identifying and making recommendations on improvement opportunities.

KNOWLEDGE/EXPERIENCE:

• Bachelors degree in a scientific discipline is an advantage
• Minimum of 3 years in a Quality Assurance role in Medical Device or Pharma is preferred.
• Excellent verbal and written communication skills
• Ability to work in a cross functional team
• Good command of MS Office – Word, Excel, PowerPoint
• Working knowledge and understanding of QSR and ISO quality system requirements
• Lead Auditor certification or previous auditing experience is preferred

Benefits:
Pension