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