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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
