QMS Design Lead - Healthcare Software -SaMD - Urgent

Experis - ManpowerGroup; London; On-site; GBP 125,000 - 150,000; Full time

Job summary

A leading staffing agency is looking for a Quality Management Specialist to manage the QMS strategy for SaMD in London. You will lead ISO 13485 gap analysis and integrate QMS into agile workflows. The ideal candidate has deep ISO 13485 expertise in healthcare software and a proven track record in regulated environments. This role offers immediate start opportunities.

Qualifications

• Deep ISO 13485 expertise in healthcare software.
• Proven track record from QMS design to accreditation.
• Confident communicator with top-tier documentation skills.

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 in healthcare software

Agile/DevOps in regulated environments

Strong 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,

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