Our Client based in Shannon Co. Clare is seeking an experienced Quality Engineer to join their dynamic team. The purpose of this role is to develop, establish and maintain quality systems and practices which meet the company, customer and regulatory requirements.
DEPARTMENT: Quality
REPORTING TO: Quality Manager
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 the company’s 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 at the company.
KNOWLEDGE/EXPERIENCE:
- Bachelor’s 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
Skills:
Quality Engineer, QA
