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Quality Systems and Medical Device Governance Manager | Guy's and St Thomas' NHS Foundation Trust

Dyddiad hysbysebu:	14 Mawrth 2025
Cyflog:	Heb ei nodi
Gwybodaeth ychwanegol am y cyflog:	£61,927 - £68,676 p.a. inc HCA
Oriau:	Llawn Amser
Dyddiad cau:	13 Ebrill 2025
Lleoliad:	London, SW3 6NP
Cwmni:	Guys and St Thomas NHS Foundation Trust
Math o swydd:	Parhaol
Cyfeirnod swydd:	7048305/196-LIS9372

Crynodeb

Clinical Engineering at Royal Brompton and Harefield hospitals supports the medical equipment of the two sites as well as supporting the hospitals’ programmes of care and research through the design and construction of specialist devices

You will be working at both sites and there may be occasional requirement to visit other Guy’s and St Thomas’ sites

We are seeking for a highly motivated quality manager to improve and maintain our existing ISO Quality Systems (QS)
• Harmonising processes to improve efficiency, device safety and patient outcomes
• Ensuring that the QS support the availability, reliability and suitability of the medical equipment
• Advising on the medical device regulations applied to novel medical devices and maintaining project documentation

And as Medical Devices Safety Officer (MDSO) creating a programme of medical device safety improvement
• Improving the frequency and quality of incident reports involving medical devices
• Ensuring effective response to manufacturer and MHRA medical device safety notices, alerts from Central Alerting System (CAS), etc.
• Investigating serious device related incidents using a systems approach

Our ideal candidate will have
• Experience in healthcare technology, maintenance, or management
• Expertise in the ISO quality standards and medical device regulations having managed, developed, implemented or worked to an ISO 9000/13485 quality system
• Candidates who do not meet the full person specification may be considered at a lower grade

Leads the development and operation of the Clinical Engineering ISO13485 and ISO9001 quality systems, focussing on cross-site harmonisation of processes to improve efficiency, device safety and patient outcomes, and ensuring the quality systems support the medical equipment fleet availability reliability and suitability.

In conjunction with the Head of Clinical Engineering leads medical device governance for the Royal Brompton and Harefield Hospitals creating a programme of medical device safety improvement including
• Improving the frequency and quality of incident reports involving devices
• Responding to nationally reported device safety initiatives
• Creating and maintaining an effective medical device inventory
• Be responsible for the management of the departmental Quality Management software (QPulse) and Medical Equipment Management software and database (AIMS)

Acts as the local medical devices safety officer (MDSO), ensuring the Trust responds effectively to manufacturer and MHRA device safety notices.

Leads on the investigation of serious device related incidents or significant near misses using a systems approach, implementing the necessary changes in procedure, training, or culture to reduce the likelihood of reoccurrence.

As a member of the devices design team advises on the requirements of the medical device regulations for novel medical devices to ensure a compliant risk reducing production process allowing devices to be CE/UKCA marked under the ISO 13485 system.

Royal Brompton & Harefield Hospitals as part of Guy’s and St Thomas’ is the largest heart and lung centre in the UK and among the largest in Europe. We are a partnership of two specialist hospitals which are known throughout the world for their expertise, standard of care and research success.

Main tasks and responsibilities



Communication

The post holder is responsible for



· Communicating with a very wide range of professional groups
• • senior medical, management and technical staff within the Trust,
• medical equipment manufacturers,
• service providers and
• national standard/regulatory bodies

regarding equipment use, faults, hazards, training or technical issues.



· Investigating incidents to clarify facts including talking to staff involved, with the aim of eliminating conjecture and unfounded assumptions. This work may involve communicating with staff who are emotionally affected by events, or angry or defensive about their role in an incident.



· Discussing highly complex engineering and technical problems with suppliers or manufacturers when investigating incidents or near misses caused by faults or substandard performance of medical equipment or devices. There will often be a need for persistence, tact, discretion and negotiation to achieve an effective outcome that improves safety.



· When required acting as the liaison with the MHRA when reporting or investigating device related incidents.



· Investigations must be carried out in with a clear sense of the Trust’s “no blame” culture.



· Contributing to the Clinical engineering senior management team meetings with the Head of Clinical Engineering, Operations Manager, Technical Support Engineer, Harefield Clinical Engineering Manager and Clinical Support Team Leader to discuss technical, managerial, departmental and Trust issues



· Working in the intensive care areas, coming into contact with, and communicating with, patients and relatives when carrying out normal duties



· Representing the department on Trust committees as directed.



From time to time, contributing specialist technical advice and knowledge, as appropriate to the expertise and experience of the post holder, to both the routine and development activities of the Clinical Engineering service,





Patient/customer care (both direct and indirect)



The post holder has no specific patient care duties. However during the investigation of device related incidents attendance in the clinical area will be required and may include reviewing wounds or devices that are in use.



Policy & Service development



Quality systems



The post holder is responsible for


• At the direction of the Head of Clinical Engineering developing and overseeing the operation of the Clinical Engineering ISO13485 and ISO9001 quality systems focussing on• Improving service quality and effectiveness,
• Improving device safety,
• Improving patient outcomes by ensuring the quality systems support the medical equipment fleet’s availability reliability and suitability.
• Leading the development and operation of the Clinical Engineering ISO13485 and ISO9001 quality systems as they apply to the management of the Trusts fleets of medical equipment.
• Increasing cross-site harmonisation of Clinical Engineering processes working with the technical support teams on each site to review, rationalise and adopt best practice
• As required by ISO9001, continually monitoring and improving the quality and effectiveness of Clinical Engineering services
• Monitoring and addressing non-conformities within the quality system
• Conducting medical equipment user service satisfaction surveys. Reviewing these with the department and setting out a programme of improvements in response.
• Leading the programme of audit and inspections of the department’s quality systems to ensure certification is retained including liaison with the certifying authority.
• Planning a cross site audit calendar.
• Responding to non-conformities reported or revealed at audit, Developing a plan of corrective actions and overseeing the implementation of these in time for any re-inspection.
• Jointly leading the process of Equipment Support Service Analysis (ESSA) working with the technical support teams on each site to develop a comprehensive risk based programme of medical equipment maintenance.
• Running a programme of test equipment calibrations to meet the requirements of the department’s quality systems.



Device Governance and medical device safety



The post holder is responsible for


• In conjunction with the Head of Clinical Engineering working with the local and trustwide Medical Devices Safety Committees to improve device safety, meeting the requirements of the NHS/PSA/D/2014/006 Directive, “Improving medical device incident reporting and learning”.


• In conjunction with the Head of Clinical Engineering investigating serious device related incidents or significant near misses, either leading or participating as part of an investigative team. Investigations follow a systems approach, recommending and where appropriate implementing the necessary changes in procedure, training, or culture to reduce the likelihood of reoccurrence as far a is practically possible.


• Acting as the local Medical Devices Safety Officer (MDSO)• Representing the Trust in the NHS England National Medical Devices Safety Network.
• Responding to requests for information from the Patient Safety Domain in NHS England and the MHRA
• Supporting the dissemination of medical devices safety communications from NHS England and the MHRA throughout the organisation
• Acting as a point of contact for manufacturers and supporting local actions to complete Field Safety Notices.
• Operating the local MDSO mailbox


• Acting as the local medical device governance manager leading a programme of medical device safety improvement including• Improving the frequency and quality of incident reports involving devices
• Responding to nationally reported device safety initiatives
• Creating and maintaining an effective medical device inventory
• Leading the improvement of device related incident reporting in the Trust





Resource management



Clinical Engineering modifies and manufactures medical equipment and devices to strictly limited budgets from research grants or NHS revenue.

The post holder is responsible for
• Monitoring the expenditure of funding against project budgets. Highlighting potential overspends to the project design teams.
• Managing the sale of devices to outside bodies, projecting potential sales.
• Evaluating the cost of attaining CE marking against the potential for sales outside the Trust
• Purchase



People management

The post holder is responsible for


• Training clinical staff in good incident reporting practice emphasising the need to improve the frequency and quality of incident reports involving medical devices, encouraging staff to report• Frequently including near misses.
• Promptly and as close to the incident as possible
• Objectively and factually as possible to enable effective post incident analysis.
• Training staff how to secure and quarantine equipment involved in incidents.



Training Clinical Engineering staff
• How to operate the department’s quality systems.
• On good incident investigation practice



Information management

The Clinical Engineering department operates a medical equipment asset database within which the full equipment lifecycle is recorded.

The post holder is responsible for

· Be jointly responsible for the management of the departmental Quality Management software (QPulse) and Medical Equipment Management software and database (AIMS)
• Recording the department’s responses to field safety notices
• Reporting statistics to the Head of Clinical Engineering as requested
• Using the database to determine trends in reliability or to detect underlying faults
• Reporting equipment and device related incident investigations using the Trust’s reporting system (RADAR)



Research and development



Clinical engineering modify or manufacture medical devices for clinical and research use under an ISO13485 certification. The post holder is a member of the devices design team.

The post holder is responsible for
• Advising on the requirements of the medical device regulations for novel medical devices.
• Applying the classification rules for medical devices and devising a plan for demonstrating a compliant production process based around risk reduction
• Creating a risk based design dossier for in-house manufactured or modified devices.
• Capturing the evidence required and for CE/UKCA marking under the ISO 13485 system
• Managing the registration of CE/UKCA marks with the MHRA. Notifying the MHRA of in-house made or modified devices
• Contributing specialist technical knowledge to project designs within their experience and competence.



Further sections



· To abide by the Trust’s Core behaviours for staff and all other Trust policies, codes and practices including standing financial instructions, research governance, clinical governance, patient and public involvement, codes and practices, and health and safety.



Other duties

To undertake any other duties commensurate with the grade as requested.


This advert closes on Monday 31 Mar 2025