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 with the pertinent regulations
* Lead and execute upgrades to the quality system
* Participation, coordination, 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:
* 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, and 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
If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.