Overview

My consultancy client is looking for a QMS lead with deep SaMD expertise to shape the future of digital healthcare services. You will lead the design, implementation, and continuous improvement of our ISO 13485-aligned QMS for our cutting-edge software which will be classified as Software as a Medical Device (SaMD).Responsibilities

Own the QMS vision and strategy for the SaMD programme.Ensure full alignment with ISO 13485, IEC 62304, and ISO 14971 standards.Embed QMS principles into agile product squads without compromising delivery velocity.Strong understanding of software development life cycles (Agile, DevOps) in regulated environments.Prepare the organisation for external audits and ISO accreditation.Champion a culture of continuous improvement and quality-first thinking.Qualifying expertise

Deep SaMD expertise.Experience aligned with ISO 13485, IEC 62304, and ISO 14971 standards.If this sounds of interest please send me your CV ASAP for review.

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