Job Description
We are seeking a Quality Systems Engineer to join our Centre of Excellence for Manufacturing in Dublin.
The successful candidate will be responsible for implementing and maintaining our quality management systems in line with industry standards and regulations.
To be successful, you will have a degree in science or engineering and a minimum of 5 years' experience working in a medical device or pharmaceutical regulated industry.
You will have experience working with established quality systems, leading CAPAs and internal audits, and ideally hold a qualified internal auditor certification.
Responsibilities:
* Drive cGMP practices within Operations and Quality divisions
* Consult with other departments to provide quality oversight and ensure compliance
* Ensure adherence to internal and external regulatory requirements
* Support the internal audit team and participate in external audits
* Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA
* Prepare and present data to management on quality system performance
* Drive thorough investigation and root cause analysis of CAPAs and Internal Audit findings
* Support process improvement activities
* Provide quality review of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation