QMS Design Lead - Healthcare Software -SaMD - Urgent

Experis; City Of London; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A leading recruitment service is seeking a Strategic QMS Lead to build and embed an ISO 13485-aligned Quality Management System for a healthcare platform. The ideal candidate will drive compliance, liaise with teams, and prepare the business for audits and accreditation. Experience in healthcare software and Agile environments is essential. This role offers an immediate start and UK-wide opportunities.

Qualifications

• Deep ISO 13485 expertise in healthcare software.
• Proven track record from QMS design to accreditation.
• Strong grasp of Agile/DevOps in regulated environments.

Responsibilities

• 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.

Skills

ISO 13485 expertise

Agile/DevOps knowledge

Strong communication skills

Documentation skills

Tools

AI-enabled QMS tooling

QMS design tools

Job description

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