QMS Design Lead - Healthcare Software -Samd - Urgent

Experis IT; London; On-site; GBP 65,000 - 85,000; Full time

Job summary

A leading IT recruitment agency is seeking a strategic QMS Lead in London to develop an ISO 13485-aligned Quality Management System for a healthcare platform. You will lead compliance initiatives, embed quality processes within agile teams, and communicate with regulators while driving a culture of continuous improvement. Immediate start available for qualified candidates.

Qualifications

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

Responsibilities

• Own the QMS strategy for SaMD.
• Lead ISO 13485 gap analysis and implementation.
• Train and promote QMS adoption across tech teams.

Skills

ISO 13485 expertise

Agile/DevOps experience

Strong documentation skills

Communication skills

Experience in pharma or MedTech

Familiarity with ISO 14971

AI-enabled QMS tooling

Job description

Overview

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