QMS Design Lead - Healthcare Software -Samd - Urgent

Experis; London; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading healthcare consultancy is seeking a QMS Lead to develop an ISO 13485-aligned Quality Management System for a healthcare platform in London. The ideal candidate will drive compliance, shape governance, and collaborate closely with agile product teams. Experience in QMS design, strong communication skills, and familiarity with AI-enabled tooling are essential for this immediate role.

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.
• Deliver training and drive adoption across tech teams.

Skills

ISO 13485 expertise

Agile/DevOps experience

Strong communication skills

QMS design to accreditation experience

Documentation skills

Tools

AI-enabled QMS tooling

ISO 14971

IEC 62304

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