Job Description
Our client is a leading global provider of optimized manufacturing solutions for high precision products with services including: engineering and design-for-manufacture; mould-making; sampling & development; injection moulding primarily for the electronics sector; value-added contract manufacturing operations; multi-shot technologies; scalable automation and turnkey manufacturing systems.
JOB PURPOSE:
To assist the Quality Manager in the implementation of our clients Quality Management System. Support the overall quality team.
RESPONSIBILITIES:
The Quality Engineer (QE) 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:
- 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, coordinating product/production related NCR’s to closure in a timely manner
- Establishing and monitoring inspection standards, plans, frequencies, and test methods
- Establishing and maintaining FMEA’s.2
- 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.
- Performing 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 from QAHOLD 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 our clients procedure comply with GDP.
- Adherence to incoming control requirements and supporting the SCAR process when required.
- Audit experience advantageous.
- Perform additional duties at the request of the Quality Manager
- Hold a relevant 3rd level qualification and/or equivalent quality experience (1+ yrs @ similar level) ideally in high volume manufacturing
- Have good communication and interpersonal skills
- Be a team player with the ability to work independently
- Be proactive and solutions driven in their approach