Quality Engineer (Medical Devices)
Our client, an innovative medical device business based near Fareham in Hampshire, is seeking a Quality Engineer to support the development and continuous improvement of its Quality Management System. Working within a growing medical technology environment. This permanent, hybrid position is focused on quality systems, compliance and auditing. The successful applicant will help maintain audit readiness, support regulatory compliance and embed practical quality processes across the business.Key Responsibilities:Maintain and improve digital and paper-based elements of the Quality Management SystemPlan, conduct and report on internal auditsSupport external audit readiness, including evidence packs, responses and follow-up actionsSupport compliance with ISO 13485 and quality risk activities aligned with ISO 14971Apply knowledge of ISO 9001 and quality engineering principles within a regulated medical device environmentManage controlled updates to procedures, forms and quality recordsSupport CAPA and continuous improvement activities arising from audits and quality findingsWork collaboratively with stakeholders to establish consistent and effective quality practicesJob Requirements:Experience in Quality Engineering or Quality Compliance within the medical device sectorStrong working knowledge of ISO 13485 and an understanding of ISO 14971Knowledge of ISO 9001, quality management systems and regulatory complianceExperience supporting internal and external audit cycles for medical ..... full job details .....
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