Cache of job #13941293

Job Title

Senior Quality Engineer

Employer

Brightwater

Location

Waterford

Description

One of the leading employers in Waterford is seeking an experienced and dynamic Quality Engineer to support R&D and NPI at their new, state of the art manufacturing facility. This 12 month contract role carries a strong salary and benefits package and requires someone with a track record of delivering real results. You'll work in a high performing team and in return you'll be rewarded with a supportive culture in a great working environment. About the Job: Work closely with R&D during the development and introduction of new products and technologies. Work with R&D team to ensure Suppliers associated with new production introductions are Qualified as per Supplier Qualification requirements. Work with the R&D Team to ensure that all Quality Control Requirements for new products, and technologies are defined and understood and that they are transferable and maintainable in a production environment. Lead failure analysis PFMEA, to ensure functional specification requirements are fully met during validation. Technically understand the process in question, and provide input to and approval of, development protocols, process validation protocols, inspections and analysis of results. Drive the resolution, analysis and problem solving of 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. Additional requirements of the job will be specified by the Quality Systems Manager. About You: Third level Degree Qualification in Science or Engineering. Minimum 3-5 years’ experience in a regulated pharmaceutical/medical device with at least 2 years in a senior Quality Role essential. Full understanding and experience of the requirements of ISO 13485, 21 CFR Part 820 and Part 11 and data integrity requirements essential. Knowledge of Supply Chain and the Supplier Qualification requirements an advantage. Experienced lead auditor an advantage. Experience in providing Quality Support for Product Development and validation beneficial. Must be self-motivated, with ability to work on own initiative and prioritize. Must have experience of team working and excellent communication skills with the ability to motivate and influence people and drive corrective actions when necessary. High attention to detail. Statistics/Six Sigma Qualification beneficial. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

Date Added

2017 days ago

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