Senior SaMD Quality Lead: QMS, CAPA & Software Release

Medibeam; Greater London; Hybrid; GBP 70,000 - 95,000; Full time

Benefits offered by this job

30 days holiday + bank holidays

Job summary

Medibeam is seeking a Senior Quality Specialist to join its growing health-tech team in London. You will own critical quality processes for SaMD, work with product and engineering on software releases, and help shape the evolving QMS as the company moves toward Class II software medical device classifications.

This hybrid role offers two days a week in Central London, a growth plan, and the chance to influence regulatory and quality KPIs across the organisation.

Qualifications

• SaMD experience with software as a medical device is required.
• Hands-on involvement with product and engineering on software releases and V&V.
• Experience owning part of a QMS, ideally NC and CAPA.

Responsibilities

• Own NC and CAPA tracking and root cause analysis.
• Review and sign off release documentation for software updates.
• Review V&V reports and ensure testing covers changes.
• Maintain the technical file and contribute to management reviews and KPIs.
• Work in a practical QMS environment via workflow tools.

Skills

SaMD experience

V&V collaboration

QMS ownership NC/CAPA

Software release collaboration

Device classification awareness

Job description

Medibeam is seeking a Senior Quality Specialist to join its growing health-tech team in London. You will own critical quality processes for SaMD, work with product and engineering on software releases, and help shape the evolving QMS as the company moves toward Class II software medical device classifications.

This hybrid role offers two days a week in Central London, a growth plan, and the chance to influence regulatory and quality KPIs across the organisation.