Quality Engineer - County Kildare.
JOB PURPOSE: To assist the Quality Operations Manager in the implementation of the Quality Management System.
Support the overall quality team.
KEY RESPONSIBILITIES: 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 (NCRs) 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 FMEAs.
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).
Interested applicants should hold a relevant 3rd level qualification and/or equivalent quality experience, 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.
Skills: Quality Engineer Injection Moulding Medical Device