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.
Person Specification
* Numeracy and literacy
* NVQ Level 3 or equivalent in decontamination
* IT literate
* Internal Auditor to ISO 13485:2016 and ISO 9001:2015
* Chartered Membership with IDSc
others
* ability to train and teach others with confidence
* knowledge and confidence to challenge
* Ability to motivate others
Experience
* Technical Knowledge of the reprocessing of medical devices and flexible endoscopes
* Previous experience of working ISO 13485:2016, HTM01-01/01-06 & Medical Devices Regulation
* Experience of conducting and coordinating departmental training
* Previous leadership experience in decontamination
* Experience of conducting internal audits and taking part in external audits
Personal qualities and attributes
* Work with minimal supervision
* Manage own workload
* Willingness to professional development
* Excellent ability to analyse and record data for long periods of time
Skills and aptitudes
* Excellent people management and people development skills
* Manage own workload
* Follow policies and procedures
* Ability to plan and prioritise work requirements and demands
* Competent use of Microsoft Office applications
* Excellent verbal and communication skills
Royal Free World Class Values
* Demonstrable ability to meet the Trust Values
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
£36,943 to £44,900 a yearper annum inclusive of HCAS
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