Senior Quality Engineer - Waterford

FRS RECRUITMENT

WATERFORD

Senior Quality Engineer- Waterford. Excellent opportunity for a Senior Quality Engineer to join a Healthcare company in Waterford. You will be joining a highly sought- after company and working within a friendly and supportive team. You will report to the Quality Systems Manager and support R&D projects and New Product Set Ups from a Quality Perspective. You will ensure compliance of. Quality management system at all times, You will get to: Work with R&D during the early phases of new products and technologies. Ensure Quality Control Requirements for new products and technologies are set out and understood and that they are transferable within manufacturing environment. Lead failure analysis, to ensure functional specification requirements are met during validation phase. Support validation processes by approving documentation associated with new product validations and technologies. Technically understanding to develop protocols, process validation protocols, inspections and analysis of results. Work with the Project Team to achieve a robust process in compliance with regulations and requirements. Track and trend data on Quality performance of new product introductions and technologies. Problem solve for new product related issues, working closely with both manufacturing Quality and R&D. Lead CAPA/Nonconformance activity when required. Ensure the efficient and timely transfer of Quality knowledge to manufacturing quality engineers and coordinate the training of quality engineers and quality technicians on new quality systems and equipment and products. Ensure all cGMP and GDP are followed at all times. Requirements: Degree in Engineering or Science discipline. Minimum 3-5 years experience in a regulated pharmaceutical/medical device environment. Excellent working knowledge of ISO 13485. Experience in providing Quality Support for Product Development and validation beneficial. Must have the ability to analyse and provide Quality Direction on product/equipment issues using independent judgement. Statistics/Six Sigma Qualification Beneficial. For more information please don't hesitate to call Aoife on 086 044 3981 to discuss the role in more detail. You may also have searched for: QE Job Cork, Senior Quality Engineer Job Cork, NPI Engineer Job, QE Job Cork, Senior Quality Engineer Job Cork, NPI Engineer Job.

1626 days ago