Quality Management Systems - Samd - Digital Health Platform

Experis; London; On-site; GBP 60,000 - 85,000; Full time

Job summary

A consultancy firm in London seeks a QMS lead to shape the future of digital healthcare services. Your main responsibilities will include leading the design and implementation of a QMS aligned with ISO standards for software classified as Software as a Medical Device. Candidates should have deep expertise in SaMD and experience with ISO regulations. This role requires the ability to embed quality principles into agile teams and prepare for external audits.

Qualifications

• Experience aligned with ISO 13485, IEC 62304, and ISO 14971 standards.

Responsibilities

• Own the QMS vision and strategy for the SaMD programme.
• Ensure full alignment with relevant standards.
• Embed QMS principles into agile product squads.
• Prepare the organisation for external audits.
• Champion a culture of continuous improvement.

Skills

Deep SaMD expertise

Understanding of software development life cycles (Agile, DevOps)

Job description

Overview

My consultancy client is looking for a QMS lead with deep SaMD expertise to shape the future of digital healthcare services. You will lead the design, implementation, and continuous improvement of our ISO 13485-aligned QMS for our cutting-edge software which will be classified as Software as a Medical Device (SaMD).

Responsibilities

• Own the QMS vision and strategy for the SaMD programme.
• Ensure full alignment with ISO 13485, IEC 62304, and ISO 14971 standards.
• Embed QMS principles into agile product squads without compromising delivery velocity.
• Strong understanding of software development life cycles (Agile, DevOps) in regulated environments.
• Prepare the organisation for external audits and ISO accreditation.
• Champion a culture of continuous improvement and quality-first thinking.

Qualifying expertise

• Deep SaMD expertise.
• Experience aligned with ISO 13485, IEC 62304, and ISO 14971 standards.

If this sounds of interest please send me your CV ASAP for review.