Quality Assurance Engineer

5 Days Old

Elevation Recruitment Group are working exclusively with a growing and innovative medical device manufacturer. They are seeking a  Quality Engineer  to join their friendly and collaborative QA team. This is a newly created role due to increasing workload, offering the chance to make a real impact and grow within the business. The Role As part of the Quality Assurance team, you’ll support and develop the company’s Quality Management System (QMS), lead manufacturing validations, and ensure compliance with ISO 13485 and ISO9001. You’ll work cross-functionally with Manufacturing, Quality, and R&D to drive improvements, resolve compliance issues, and support audit readiness. Key Responsibilities Maintain and improve the QMS to ensure compliance and support business needs. Manage and review manufacturing documentation – PFMEAs, validations etc. Drive continuous improvement using Lean and Six Sigma methodologies. Support CAPA, non-conformance investigations, and audit preparation. Develop training and quality documentation for production processes. Support complaints handling and vigilance reporting. About You Experience in a highly regulated sector (Essential) Strong understanding of ISO 13485 and AS9100. Proven skills in validation, quality documentation, a...
Location:
Sheffield
Salary:
£38,000 - £42,000 per annum
Category:
Manufacturing & Purchasing

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