What you need to know
You will work as a Quality Engineer for our client, a highly successful manufacturing company based in Kildare.
This is a permanent role.
As the Quality Engineer, you will assist the Senior Quality Engineer in the implementation of the company Quality Management System.
- Overall responsibility for production GMP standards and compliance in production
- 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 NCR’s to closure in a timely manner
- Establishing and monitoring inspection standards, plans, frequencies and test methods
- Establishing and maintaining FMEA’s.
- Preparing and updating Operations procedures and associated documentation
- Reporting area of responsibility metrics
- 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 ISO/FDA/MDD and other Product Development related regulatory requirements
- Develop strong links with customer organisation’s and other project stakeholders
- Quality function responsibility for area validation documentation
- 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.
- Controlling documentation and ensuring good documentation practices; Management of customer documents into the Quality system i.e. Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
- Completing internal audits.
- 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 company procedure comply with GDP, are filed correctly and are up to date.
- Adherence to incoming control requirements and supporting the SCAR process when required.
- Keeping well-informed on regulatory updates, interpreting regulatory drafts or submissions to understand impact to the company and lead updates as required. The responsibility shall also extend to the advice on compliance risk issues and driving improvement actions. Remain aware of developments in the quality field by reading current quality / regulatory literature and attending relevant meetings and workshops. Monitor local Regulatory Environment and feed-back to relevant stakeholders
- Maintain a comprehensive audit readiness program to ensure internal and external compliance for Medicinal Product lines and associated processes
- Perform additional duties at the request of the direct supervisor.
What are we looking for
- Have a minimum of a third level qualification in a relevant field
- Have extensive and directly relevant experience in high-volume injection moulding manufacturing
- Be proficient in the use of Lean Manufacturing principles (SMED, Six Sigma, etc.).
- Possess excellent interpersonal skills and the ability to successfully manage stakeholder relationships.
- Possess excellent verbal and written communication skills.
- Have comprehensive knowledge of QMS principles (preferably ISO 13485)
- Have strong information management, analytical and numerical skills with a high level of attention to detail.
- Be a team player and capable of working independently and on own initiative.
- Be well-organised, highly self-motivated and capable of multi-tasking in a fast-paced, pressurised environment.
Apply for this job now or get in touch with Joanne on 01 4690901.
We Value Your Trust.