Lead Quality Management System Consultant, London, QMS, ISO 13485, Immediate Start, Agile, ISO 14971, AI,
My leading client is looking for a strategic Lead Quality Management System Consultant to 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 start