Band 5 Quality Officer

Job overview

The Royal Free London NHS Foundation Trust is seeking a Quality Officer to join the Decontamination Services Unit based in Enfield. The unit provides services across Sterile Services, Endoscopy, Logistics, and the Distribution Centre, supporting the reprocessing of reusable medical devices and the storage and distribution of medical consumables and capital equipment.

The post holder will support the Quality Manager in ensuring that all reprocessed surgical instruments and flexible endoscopes meet required quality, safety, and regulatory standards, including ISO 13485:2016, UK Medical Devices Regulations 2002 (as amended), HTM 01‑01, and HTM 01‑06.

The post holder will also provide quality support to the Operational Services Manager, Distribution Centre Manager, Logistics Manager, and General Manager, and will deputise for the Quality Manager at meetings where required.

The post is primarily Monday to Friday, 08:00 to 16:00. However, flexibility is required to support training activities across all operational shifts, which may include:

05:00 to 13:00

06:00 to 14:00

14:00 to 22:00

22:00 to 06:00

The post holder will also be required to support the annual weekend stocktake (Saturday and Sunday) and may be required to attend customer hospital sites across London to support quality‑related issues. Longer hours will be required to support the annual BSI audit, which takes place in November.

You will receive an enhancement of pay for working unsociable hours and at the weekend.

Main duties of the job

Quality Management System (QMS): Support the review, development, and updating of Standard Operating Procedures (SOPs), policies, risk registers, and quality documentation to ensure compliance with ISO 13485:2016, UK MDR 2002 (as amended), and relevant HTM guidance.

Audit and Compliance: Undertake regular internal audits  and actively support external audits conducted by notified and regulatory bodies, including BSI.

Non‑Conformance and CAPA: Identify in‑process errors and instrument non‑conformances, investigate root causes, and support the implementation and monitoring of effective Corrective and Preventative Actions (CAPA).

Documentation and Traceability: Ensure electronic and paper‑based records,  , and medical device traceability documentation required under UK MDR, are accurate, complete, and available for inspection.

Training and Competency: Coordinate departmental training programmes and undertake competency assessments for decontamination services staff, distribution centre operatives, and logistics staff. Coach, support and guide staff, acting as a point of quality advice and promoting a quality‑focused culture across all services.

Equipment and Environmental Monitoring: Monitor equipment testing, servicing and validation schedules, cleanroom environmental controls, and ensure all records  are maintained and reviewed in line with regulatory and manufacturer requirements.

For further details refer to the job description.

Detailed job description and main responsibilities

Please see attached job description for more information about this role and working at the Royal Free London NHS Foundation Trust.