Quality Engineer - County Kildare.
JOB PURPOSE:
To assist the Quality Operations Manager in the implementation of the Quality Management System and 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:
1. Interfacing with the customer to realise customer satisfaction.
2. Responsibility for production GMP standards.
3. Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
4. Initiating and completing CAPA actions as required.
5. Initiating and completing engineering change requests and actions as required.
6. Initiating and completing non-conformance reports (NCRs) as required, coordinating product/production related NCRs to closure in a timely manner.
7. Establishing and monitoring inspection standards, plans, frequencies, and test methods.
8. Establishing and maintaining FMEAs.
9. Preparing and updating quality system documentation.
10. Supporting customer and surveillance accreditation audits.
11. Performing an active role in quality planning and new product introduction from a quality perspective.
12. Having a good working knowledge of quality management systems (ideally ISO13485) and other product related regulatory requirements.
13. Developing strong links with customer organizations and other project stakeholders.
14. Validation experience would be advantageous (not essential).
15. Performing an active role in further development and continuous improvement of the quality management system.
16. Supporting Operations area projects and initiatives.
17. Training new or existing personnel on quality procedures and documentation; ensuring that production personnel are trained for their tasks and that procedures are in place.
18. Understanding customer documents i.e. Drawings, Purchase Specification, Quality Agreements etc.
19. Ensuring that on-hold material is dispositioned and actioned in a timely manner.
20. Ensuring that all retained samples are stored correctly, and that the sample storage area is maintained.
21. Ensuring that all quality records are completed as per procedure and comply with GDP.
22. Adhering to incoming control requirements and supporting the SCAR process when required.
23. Audit experience 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 and Attributes:
• Good communication and interpersonal skills.
• Team player with the ability to work independently.
• Proactive and solutions driven in their approach.
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