Quality Engineer - County Kildare
To assist the Quality Operations Manager in implementing the Quality Management System and supporting the overall quality team.
Key Responsibilities:
* Monitor production and release of finished parts, ensuring adherence to quality policies and procedures daily, in accordance with the Quality Management System.
* Interface with customers to realize customer satisfaction.
* Maintain production GMP standards.
* Investigate root causes and follow through on effective corrective actions to prevent recurrence of customer and internal quality issues.
* Initiate and complete CAPA actions as required.
* Initiate and complete engineering change requests and actions as required.
* Initiate and complete non-conformance reports (NCRs) as required, coordinating product/production-related NCRs to closure in a timely manner.
* Establish and monitor inspection standards, plans, frequencies, and test methods.
* Establish and maintain FMEAs.
* Prepare and update quality system documentation.
* Support customer and surveillance accreditation audits.
* Participate actively in quality planning and new product introduction from a quality perspective.
* Develop strong links with customer organizations and other project stakeholders.
* Validation experience is advantageous (not essential).
* Contribute to the further development and continuous improvement of the quality management system.
* Support Operations area projects and initiatives.
* Train new or existing personnel on quality procedures and documentation; ensure production personnel are trained for their tasks and that procedures are in place.
* Understand customer documents, i.e., Drawings, Purchase Specifications, Quality Agreements, etc.
* Ensure that on-hold material is dispositioned and actioned in a timely manner.
* Ensure that all retained samples are stored correctly and that the sample storage area is maintained.
* Ensure that all quality records are completed per procedure and comply with GDP.
* Adhere to incoming control requirements and support the SCAR process when required.
* Audit experience is advantageous (not essential).
Minimum Qualifications:
* Interested applicants should hold a relevant 3rd level qualification and/or equivalent quality experience, ideally in high-volume manufacturing.
Skills:
* Good communication and interpersonal skills.
* Ability to work as a team player and independently.
* Proactive and solutions-driven approach.