Quality Management Systems - SaMD - Digital Health Platform

Experis; Greater London; On-site; GBP 55,000 - 75,000; Full time

Job summary

A leading consultancy in healthcare technology seeks a QMS lead to shape the future of digital healthcare services. The ideal candidate will manage the ISO 13485-aligned QMS, ensuring compliance with necessary standards and promoting continuous improvement within agile product squads. Strong experience with SaMD, Agile, and DevOps is essential. Please submit your CV ASAP for review.

Qualifications

• Proven experience in the design and implementation of QMS.
• Ability to prepare organizations for external audits.
• Strong understanding of software development lifecycle in regulated environments.

Responsibilities

• Lead the design and continuous improvement of the ISO 13485-aligned QMS.
• Ensure alignment with ISO standards for SaMD.
• Champion a culture of continuous improvement.

Skills

Deep SaMD expertise

Agile methodologies

DevOps

ISO 13485 knowledge

IEC 62304 understanding

Quality Management System principles

Job description

Overview

QMS, SaMD, ISO 13485, IEC 62304, ISO14971, Medtech, Digital Healthcare, Software Development Lifecycle, Agile, Dev Ops

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). The key areas of expertise are to

• 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

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