Quality Manager - Part-Time

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)