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:
- 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
Benefits:
Pension
