Our client in West Dublin is currently looking to recruit a Quality Engineer will support NPI projects and will provide the company with the technical, and quality resources to manage the quality deliverables on selected NPI projects. Coordinate the necessary activities for ensuring the timely closure of internal/external quality issues on projects. This will be a 1 year contract.
- Review and approval of validation documentation
- Generating, communicate and updating the document tracker.
- Ensure the archiving and filing of validation documentation associated with the project including the management of same on MasterControl
- Facilitate equipment process and / or Design FMEA and ensure, with the Program Manager
- Leading the review and disposition of all quality attribute
- Drive the close out of change control, deviations, quality continuous improvement identified during the project.
- Lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented and learning taken into Scale up.
- Drive solutions in conjunction with the appropriate department to ensure customer related problems/issues are communicated and corrective actions are in place and closed in a timely manner.
- Prepare data/presentations and attend quality review meetings with the customer
- Set-up of Quality controls to ensure a smooth and effective handover to Operations
- Implement best practices principles into TGE QMS as applicable.
- Support internal and supplier audits.
- Trending and tracking of quality data to drive improvements
- Must have a third level qualification, at a minimum to degree level, in Engineering/Quality/Science.
- Must have a minimum of 2 years’ post graduate experience of working in a high volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector.
- A thorough working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 is essential.
- Good understanding of computer system validation.
- Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
- Must have excellent communication skills both oral and written.
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred.
- Must be able to prioritize and organise tasks.
If you are interested in hearing more about this position please contact Aoife Lomasney for a confidential chat on 0214297900 or email CV to email@example.com