We have partnered with an exciting, well established organisation in City West who are looking to hire a Quality Engineer to join their quality team. This is an excellent opportunity for you to further your career in Quality management.
The Quality Engineer will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations.
- Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
- Document control and review/approval of controlled documents
- Change management and review of change controls
- Investigation and CAPA management, including robust root cause analysis
- Complaint management and performance of complaint investigations
- Supplier quality management and performance of supplier audits as appropriate
- Internal audit program and performance of internal audits
- Training program; conduct training when needed
- Implementation of Quality Risk Management in relevant aspects of the QMS
- Management Review
- ISO certification and maintenance
- Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.
- Customer support, including:
- Support customer audits, including response and corrective action tracking
- Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication.
- Lead and/or support the oversight of product realisation and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management.
You will have
- Bachelors degree
- 2+ years experience
- Full Drivers licence
- Strong knowledge of ISO and/or cGMP requirements and relevant industry standard practices is required
- Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment
- Demonstrated understanding of Lean Manufacturing concepts
- Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project
- Excellent problem solving skills
- Excellent communication skills
To discuss in confidence please contact Eoghan at Clark