QMS Design Lead - Healthcare Software -SaMD - Urgent

Outside IR35, Uk wide, Quality Management, London, QMS, ISO 13485, Immediate Start, Agile, ISO 14971, AI,

My leading client is looking for a strategic QMS Lead to build and embed an ISO 13485-aligned Quality Management System for a cutting-edge healthcare platform. You''ll drive compliance, shape governance, and prepare the business for audits and accreditation-all while working closely with agile product teams.

What You''ll Do:

• Own the QMS strategy for SaMD.
• Lead ISO 13485 gap analysis and rollout.
• Embed QMS into agile workflows across product squads.
• Deliver training and drive adoption across tech teams.
• Liaise with auditors and regulators.
• Champion continuous improvement and quality culture.

What You''ll Bring:

• Deep ISO 13485 expertise in healthcare software.
• Proven track record from QMS design to accreditation.
• Strong grasp of Agile/DevOps in regulated environments.
• Confident communicator with top-tier documentation skills.

• Experience in pharma or MedTech platforms.
• Familiarity with ISO 14971, IEC 62304.
• Exposure to AI-enabled QMS tooling.

If this role is of interest please send me your cv ASAP, this is an immediate role