Login to Apply

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)