Quality Engineer - Co. Kildare

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 (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).

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.