Our client a medical device company in Galway is looking to hire a Supplier Quality Engineer for their site on a permanent basis.
Quality and Reliability Engineering Teams analyse the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labour, as well as failure analysis, root cause, corrective action and customer communication.
- Functional expert for Supplier approval process.
- Reporting area of responsibility metrics.
- Coordinate documentation required for determination of critical suppliers, this will involve obtaining input from the engineering team and suppliers for each new component sourced.
- Liaise with suppliers to obtain supplier approval documents.
- Manage suppliers on an on-going basis via regular contact, periodic audits and other methods to guarantee consistent high-quality performance on an on-going basis.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Interact with suppliers to resolve quality issues through the NC/SCAR process and lead quality improvement initiatives with suppliers.
- Manage the return of samples and lots to suppliers as necessary.
- Technical/quality evaluation of new suppliers / new raw material items.
- Monitor and measure performance of suppliers for quality and delivery and provide input to management review.
- Inventory control of material awaiting inspection.
- Responsibility for MRB areas as assigned to supplier issues.
- Manage Incoming Inspection department.
- Assess and implement Supplier changes.
- Level 8 degree in Engineering or Science. ·
- 4+ years industry experience in a medical device-manufacturing or pharmaceutical environment.
- Lead auditor certification.
- Have obtained a green belt in Six-Sigma or have a good working knowledge of the principles.
- Experience as a supplier Quality Engineer in a similar type role within a medical devices industry.
- Excellent “hands-on” technical skills.
- Excellent communication and inter-personal skills.
- Highly organized with strong ability to prioritize tasks and work on own initiative.
- Strong knowledge of ISO and FDA quality requirements.
- Excellent written and oral communication skills essential.
For further information on this Supplier Quality Engineer role in Galway please contact Clara Burke on 086 8168273 / email@example.com
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