Quality Management Systems - SaMD - Digital Health Platform

QMS, SaMD, ISO 13485, IEC 62304, ISO14971, Medtech, Digital Healthcare, Software Development Lifecycle, Agile, Dev Ops

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 a cutting-edge software which will be classified as Software as a Medical Device (SaMD).

The key areas of expertise are to

• 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

If this sounds of interest please send me your CV ASAP for review