Description:
The Quality Engineer shall be responsible for monitoring the production and release of finished parts and ensuring quality policies and procedures are adhered to on a daily basis, in accordance with the requirements of the Quality Management System. This includes but is not limited to:
- Interfacing with the customer to realise customer satisfaction.
- Responsibility for production GMP standards
- Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
- Initiating and completing CAPA actions as required.
- Initiating and completing engineering change request and action as required.
- Initiating and completing non-conformance reports (NCR’s) as required, co-ordinating product/production related NCRs to closure in a timely manner.
- Establishing and monitoring inspection standards, plans, frequencies, and test methods
- Establishing and maintaining FMEA’s.
- Preparing and updating quality system documentation
- Supporting customer and surveillance accreditation audits.
- The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
- Have a good working knowledge of quality management systems (ideally ISO13485) and other product related regulatory requirements.
- Develop strong links with customer organisations and other project stakeholders.
- Validation experience would be advantageous (not essential).
- Will perform an active role in further development and continuous improvement of the quality management system.
- Support Operations area projects and initiatives.
- The training of new or existing personnel on quality procedures and documentation; ensuring that production personnel are trained for their tasks and that procedures are in place.
- Understanding of customer documents i.e. Drawings, Purchase Specification, Quality Agreements etc.
- Ensuring that on-hold material is dispositioned and actioned in a timely manner.
- Ensuring that all retained samples are stored correctly, and that sample storage area is maintained.
- Ensuring that all quality records are completed as per procedure and comply with GDP.
- Adherence to incoming control requirements and supporting the SCAR process when required.
- Audit experience advantageous (not essential).