Part-Time Quality Manager
Our client an early-stage digital health company developing software products that support people living with serious mental illness. Our technology is used within healthcare settings, where quality, safety, and information security are critical.
As a growing organisation, we are focused on building a values-led culture where everyone can thrive, contribute meaningfully, and do their best work.
The Role
Our client is seeking an experienced Part-Time Quality Manager to own and lead our quality, information security, and regulatory compliance frameworks. This is a hands-on role with significant autonomy and influence, reporting directly to the Chief Operating Officer.
You will work closely with in-house technical teams and an external specialist governance consultancy to ensure that systems, processes, and software meet regulatory, security, and customer expectations.
This role is well suited to a quality professional seeking a flexible, part-time position with genuine ownership in a scaling digital health organisation.
Key Responsibilities
Quality & Regulatory Leadership
Own and maintain the organisation’s Quality Management System (QMS) in line with ISO 13485
Act as the internal lead for the ISO 27001 Information Security Management System (ISMS)
Ensure ongoing compliance with HIPAA, DTAC, NHS DSP Toolkit, and Cyber Essentials Plus
Plan, coordinate, and support external audits, assessments, and certifications
Manage internal audits, non-conformances, and corrective and preventive actions (CAPA)
Ensure policies, procedures, and records are controlled, current, and audit-ready
Software Quality & Testing
Lead and coordinate software testing activities, including test planning, execution, and documentation
Define and maintain software testing strategies aligned with regulatory and quality requirements
Work closely with engineering and product teams to embed quality and risk management into the software development lifecycle
Ensure validation, verification, and release processes meet regulatory expectations
Risk, Governance & Continuous Improvement
Lead risk management activities, including product and information security risk assessments
Support data protection, security, and (where relevant) clinical safety governance activities
Identify and drive continuous improvement opportunities across quality and compliance processes
Provide pragmatic guidance that balances regulatory requirements with business agility
Stakeholder Engagement
Act as a key internal and external point of contact for quality and compliance matters
Translate regulatory requirements into clear, practical guidance for non-specialist stakeholders
Support leadership with compliance reporting and customer or partner due diligence
Key Authorities
Authority to coordinate and maintain ISO 13485 and ISO 27001 management systems
Authority to coordinate evidence and submissions for DTAC, NHS DSP Toolkit, and Cyber Essentials Plus
Authority to support planning and delivery of software testing, internal audits, and external assessments
Authority to raise quality, safety, and information security risks and improvement recommendations to leadership
Skills & Experience
Essential
Proven experience in a Quality Manager or senior quality role
Strong working knowledge of ISO 13485 and ISO 27001
Experience with HIPAA, DTAC, NHS DSP Toolkit, and Cyber Essentials Plus
Experience leading or coordinating software testing in a regulated environment
Hands-on experience managing audits and maintaining certifications
Ability to work independently and prioritise effectively in a part-time role
Excellent communication skills, with the ability to translate regulatory requirements into practical actions
Desirable
Experience in digital health or other regulated software environments
Understanding of secure software development practices
Experience working within small, scaling organisations
Formal auditor qualification (e.g. ISO 13485 or ISO 27001 Lead Auditor)
What We Offer
£60k pro-rata
Hybrid working, with office time negotiable
Your birthday off as an additional holiday
The opportunity to build and shape quality practices in a growing digital health company
If you are interested? Please Click Apply Now!
Part-Time Quality Manager (0.5 FTE)