Quality Manager (Digital Tools) in Swadlincote

At HealthNet Homecare, we deliver specialist homecare services that support patients to manage their treatment safely and confidently in their own homes. This includes the delivery of medication and clinical support at home, across a range of therapy areas, including rare and orphan diseases. Supporting over 240,000 patients across the UK, our teams work closely with healthcare professionals to ensure treatment is delivered safely, reliably and in line with clinical standards. Our purpose is to make patients' lives easier by reducing the complexity of managing treatment, ensuring they feel informed, supported and confident they are in safe hands at every stage of their care. If you're looking for a role where your work has a genuine impact on patients' everyday lives - and where care, safety and accountability truly matter - HealthNet could be the right fit for you.

Main Responsibilities

• The Quality Manager will work with the IT and Digital teams to ensure that robust processes are in place to manage user feedback about our digital systems and software as a medical device (SaMD) product.
• The postholder will ensure accurate records are maintained, quality performance is monitored and timely reports are generated for key stakeholders.
• The role will focus on process integrity, audit readiness, and continual improvement.

Feedback, Complaints and Incident Management

• Working with IT and Digital teams ensure robust processes are in place to capture and manage user feedback about our digital systems and software as a medical device product.
• Ensure all user feedback, complaints and incidents are logged, tracked and documented in accordance with Quality Management System (QMS) procedures.
• Review all user feedback, triage and escalates appropriately issues to the Clinical Safety Officer.
• Monitor timelines, completeness and closure of all records.
• Support trend analysis and reporting to all key stakeholders.

MHRA Vigilance And Regulatory Requirements (SaMD)

• Support the administrative and quality system aspects of MHRA vigilance activities.
• Maintain quality records to support vigilance reporting (e.g. incident logs, correspondence, evidence packs).
• Support preparation of packs required by the Person Responsible for Regulatory Compliance (PRRC) and Clinical Safety Officer (CSO) for MHRA submissions.
• Track regulatory actions and deadlines as part of QMS records.

Quality Management System

• Ensure the Quality Management System documents (Standard Operating Procedures (SOPs) and records) are current, accurate and controlled.
• Support implementation of processes across all relevant departments.
• Deliver QMS and other training to ensure staff understand and follow quality procedures.
• Develop and support the implementation of ISO9001, ISO27001 and other applicable internal policies and procedures.
• Maintain awareness of quality standards relevant to the QMS.

Internal and External Audit

• Act as the primary QMS contact for external audit inspections by the MHRA in relation to SaMD.
• Coordinate audit preparation activities.
• Support audit hosting and follow-up activities.
• Track audit findings and ensure they are managed through CAPA.
• Support and administer internal audits and self-inspections of digital systems and SaMD product.

CAPA and Continuous Improvement

• Support the creation and closure of CAPA plans from the digital and IT teams.
• Maintain the CAPA register and ensure actions are clearly defined, assigned, tracked and verified for effectiveness.
• Ensure CAPAs arising from audits, incidents, complaints and process reviews are closed appropriately.
• Support identification of preventative actions and improvement opportunities.

What experience and skills are we looking for?

• Minimum 2 years' experience in a quality assurance or quality management role.
• Experience working within a regulated environment, preferably medical devices or digital health.
• Practical experience operating or maintaining a QMS aligned to ISO 13485 and/or ISO 9001.
• Experience supporting internal audits and managing CAPA.
• Formal training or certification in quality management or auditing (desirable).

Qualifications

• Degree in a relevant discipline (e.g. Quality, Engineering, IT, Healthcare, Business).

Personal Skills & Qualities

• Strong documentation and organisational skills.
• Strong verbal communication skills.
• Excellent written skills.
• Good at problem-solving.
• Ability to work independently and manage priorities.
• Ability to multi-task whilst working under pressure.
• Ability to work in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.
• Good attention to detail.
• Good team worker and supportive of others.
• Excellent IT and data management skills.
• Flexible and resilient.

Key Competencies

• Clear communicator with a collaborative working style.
• Effective time management.
• Methodical and detail oriented.
• Committed to continual improvement and quality culture.