Quality Management Systems - Samd - Digital Health Platform

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

Job summary

A leading consultancy in healthcare technology is seeking a QMS lead to oversee the design and implementation of an ISO 13485-aligned QMS for a cutting-edge software classified as Software as a Medical Device (SaMD). The role requires deep expertise in QMS and strong familiarity with software development life cycles in regulated environments. The ideal candidate will champion a culture of continuous improvement and quality-first thinking.

Qualifications

• Proven experience in leading QMS for SaMD.
• Strong understanding of software development life cycles in regulated environments.

Responsibilities

• Own the QMS vision and strategy for the SaMD programme.
• Ensure alignment with ISO 13485, IEC 62304, and ISO 14971 standards.
• Prepare the organisation for external audits and ISO accreditation.

Skills

QMS vision and strategy

ISO 13485

IEC 62304

ISO 14971

Agile methodology

DevOps practices

Job description

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 a 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