Quality Manager

JOB DESCRIPTION

Quality Manager

Responsible to:                     Director of Governance  

Purpose of Role:                   The Quality Manager will lead, develop, and maintain a robust Quality, Governance, and Compliance framework across the organisation, ensuring alignment with ISO standards, regulatory requirements, and business objectives.

Location: Sheffield Hybrid (4 days in the office, 1 WFH)

Key Responsibilities

Quality Management & Continuous Improvement

• Act as the central point of contact for day‑to‑day quality issues, ensuring timely recording, assessment, escalation, and resolution through the Quality inbox and other channels.


• Lead the development, implementation, and continual improvement of an integrated Quality Management System (QMS), including organisation-wide policies, procedures, document control, and process documentation.


• Oversee the administration and optimisation of Quality related software, ensuring accurate quality records, workflows, and reporting.


• Identify areas of quality underperformance, using quality tools and trends analysis to support operational teams in corrective and preventive actions.


• Lead non‑conformance investigations and manage the CAPA process, ensuring thorough root‑cause analysis and effective resolution, while analysing and trending data from incidents, error logs, audits, and KPIs to identify emerging risks, recurring issues, and opportunities for improvement


• Produce internal and external non-conformance reports for services, customers, and stakeholders.


• Lead and manage the end‑to‑end healthcare complaints process, ensuring timely, fair, and transparent resolution in line with statutory requirements and best practice


• Provide complex data and quality performance reports to support governance, operational, and management meetings.


• Work with operational leads to develop data extraction, dashboards, and reporting to drive a culture of quality improvement.


• Produce internal and external non‑conformance reports, along with complex data and quality performance reports, to inform services, customers, stakeholders, and support governance, operational, and management meetings


• Deliver quality-related training and awareness across all business areas.

Governance, Risk & Audit

• Develop and maintain an effective governance structure, ensuring that meetings, reviews, and reporting channels support quality, risk, and compliance oversight.


• Lead the organisation’s internal audit programme, acting as Lead Auditor and ensuring compliance with internal standards and external accreditations.


• Prepare for and support all external audits and regulatory inspections.


• Manage the company-wide risk management framework, maintaining the risk register, departmental risk assessments, and promoting a proactive risk culture.


• Ensure strong project governance across business initiatives to support compliant and high‑quality delivery.

Compliance, Standards & Accreditation

• Ensure ongoing compliance with ISO 15189, ISO 9001, ISO 27001, and ISO 14001.


• Maintain regulatory compliance including Medical Device and UKCA requirements, NHS DSP Toolkit, CQC expectations, and other relevant legislation.


• Monitor regulatory and legislative changes, providing guidance and training to ensure organisational readiness and compliance.


• Ensure quality and performance monitoring of suppliers and subcontractors.


• Support compliance with Health & Safety requirements, maintaining relevant documentation and reporting.


• Promote awareness of user needs and customer requirements across the organisation, ensuring they are reflected in quality objectives and continuous improvement activities.

Leadership & Team Management

• Lead and develop the Quality team, ensuring the function delivers a high-performing, responsive, and efficient service.


• Support the Quality department with general administrative tasks where appropriate.


• Ensure good project governance is in place for projects across the business.


• Assist in preparation for external audits.

This job description is not exhaustive and serves only to highlight the main requirements of the post holder.  The line manager may stipulate other reasonable requirements.  The job description will be reviewed regularly and may be subject to change.

Person Specification

The preferred candidate will have the following experience, abilities, and aptitudes:

Criteria

Essential

Desirable

Qualification

·         Degree preferably in a life science or equivalent experience

·         Higher level qualification

·         Quality or Health and Safety related qualification

Knowledge and

Experience

·         Proven knowledge and experience in leading and managing any ISO-certified quality management systems

·         Demonstrated ability to lead internal and external ISO audits, coordinate audit responses, and drive continuous improvement activities arising from audit findings.

·         Strong understanding of risk-based thinking, document control, non‑conformance management, CAPA processes, and quality assurance best practice.

·         Strong working knowledge of the UK healthcare regulatory landscape

·         Experience translating regulatory requirements into operational practice, ensuring services meet or exceed statutory and contractual obligations

·         Ability to interpret evolving healthcare regulations and guide the organisation in maintaining compliance.

·         Working knowledge of Health and Safety regulations and CQC requirements

Skills

·         Strong analytical and problem-solving skills.

·         Gather, analyse, use and share data to inform reports.

·         Excellent communication skills

·         Computer literate

·         Ability to work independently

·         Approachable point of contact

Equity, Diversity & Inclusion at Preventx

At Preventx, we believe diversity drives innovation and inclusion strengthens our impact. We’re committed to creating a workplace that values individual differences and fosters a culture of respect, belonging, and growth.

We welcome applications from people of all backgrounds, identities, and experiences—including those from underrepresented communities. If you need any support with your application or adjustments during the recruitment process, we’re here to help.

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·         Power BI

·         Training, Coaching and Team development