Our client a medical device company in Galway are currently recruiting for a Quality Engineer.
Reporting to the Senior Quality Engineer the Quality Projects Engineer will be responsible for driving continuous improvement within the Value Stream, working with the Engineering and Production teams.
Quality and Reliability Engineering Teams analyze 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. Our 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 labor, as well as failure analysis, root cause, corrective action and customer communication.
- Develop and implement Value Improvement Projects.
- Lead quality-related projects within the value stream e.g. where significant process changes are required that originates from a customer complaint.
- Support cost improvement projects and non re-occurring expense activities e.g. capacity expansions and new product variations within the value stream from a quality perspective.
- Provides Quality support for the transfer of new product into commercial Manufacturing.
- Provides additional support to the Operations team when a new product is introduced to the value stream where required until the product has reached steady state.
- Completion of targeted assessments for prevention reviews for new products introduced to the value stream.
- Demonstrates commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices.
- Supports validation activities within the value stream including MVP’s, MVR’s, TMV’s, OQ/PQ, PPQ and revalidation assessments.
- Supports the approval of supplier change notifications.
- Supports audits for the value stream from external regulatory agencies and customers and leads preparation activities in advance of such audits.
- Updates Quality procedures and specifications as required through the change plan process.
- Provides root cause analysis & problem-solving guidance.
- Level 8 degree in Science, Engineering or related subject.
- 3+ years relevant Supplier Quality / Quality Operations experience in good manufacturing practice manufacturing environment in Medical Device/Pharma industry.
- Project management experience.
- Green Belt qualification would be an advantage.
- Good working knowledge of validation processes.
- Ability to work as a team member.
- Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
- Good organization and investigation skills are required.
- Excellent “hands-on” technical skills.
- Excellent communication skills.
For further information on this Quality Engineer role in Galway please contact Clara Burke on 086 8168273/ email@example.com
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