About this role
Job summary
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.
About us
The Royal Free London NHS Foundation Trust is one of the UK's biggest and most innovative trusts. Across three main hospitals, our dedicated army of staff care for over 1.6million patients, treat more than 200,000 in A&E, deliver over 8,000 babies and carry out more than 17million tests.
Our size, scale and influence offer you unrivalled career opportunities and a forward-thinking approach to working that works around your lifestyle. From flexible hours and generous benefits, to next level training, we make it easier to take your career to the top.
For more information please follow link https://www.royalfreelondonjobs.co.uk/
Job description Job responsibilities
Please see attached job description for more information about this role and working at the Royal Free London NHS Foundation Trust.
Person Specification
Education & professional qualifications Essential
Numeracy and literacy NVQ Level 3 or equivalent in decontamination IT literate Internal Auditor to ISO 13485:2016 and ISO 9001:2015
Desirable
Chartered Membership with IDSc
others Essential
ability to train and teach others with confidence knowledge and confidence to challenge Ability to motivate others
Experience Essential
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 Essential
Work with minimal supervision Team worker Manage own workload Willingness to professional development Excellent ability to analyse and record data for long periods of time
Skills and aptitudes Essential
Excellent people management and people development skills Work to deadlines Manage own workload Attention to detail 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 Essential
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.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details Employer name Royal Free London NHS Foundation Trust
Address Chalkmill Drive
Chalkmill Drive
Enfield
EN1 1TZ
United Kingdom
Employer's website https://www.royalfreelondonjobs.co.uk/ (Opens in a new tab)