Quality and Information Systems Manager

Lewisham and Greenwich NHS Trust

The closing date is 18 May 2025

Job summary

This post is within the Clinical Engineering Department of the Lewisham and Greenwich NHS Trust, a large acute Trust with around 900 beds serving the population of Southeast London. This post is based at University Hospital Lewisham where there is the majority of Clinical Engineering team is based, with a smaller sized team at Queen Elizabeth Hospital making up the Clinical Engineering department. There is support between the two main sites and flexibility in working at Lewisham is required from time to time. Support to outlying community sites may also be required,

The Trust Clinical Engineering department has recently expanded as it has taken an external contract in-house and is embarked on a process of improvement to introduce a formal Quality System and integration of the inventory and job management across the Trust.

This is an excellent opportunity to be involved in a department that is expanding its role within a busy acute NHS Trust.

For further information and to arrange an informal visit please contact Andrew.Jarvis@nhs.net, EBME Manager.

Hours are 37.5 (8-5 Monday - Friday)

**Please note that interviews are face to face, and you will be expected to give a presentation at the beginning of the interview, you must be able to attend the Trust Hospital site in person**

PLEASE NOTE: We may not be able to offer sponsorship for this post

Main duties of the job

The Quality & Information System Manager is responsible for the Clinical Engineering Department ISO registration and ongoing compliance as well as the databases used within Clinical Engineering. Responsible also for co-ordinating the training programmes for ISO and databases for all clinical engineering personnel employed within the Trust and managing the paperwork associated with the Quality Systems for clinical engineering within the Organisation.

This is an operational role, the holder of this post is expected to work on one of the Trust sites Mon-Fri, with the occasional service need to work out of hours.o To maintain comprehensive training records for clinical engineering personnel relating to ISO and the databases.o To organise and co-ordinate internal/external training programmes for clinical engineering personnel.o To assist the senior management team in maintaining the departments database and ISO 13485 Quality Management System (QMS) ensuring all associated paperwork is maintained and current.o Main site of work is at University Hospital Lewisham, but the post holder may also be required to start work on any site used by the Trust. Travel between sites may be required within a working day, for example to travel between University Hospital Lewisham and Queen Elizabeth Hospital.

About us

Our people are our greatest asset. When we feel supported and happy at work, this positivity reaches those very people we are here for, the patients. Engaged employees perform at their best and our Equality, Diversity & Inclusion (EDI) initiatives contribute to cultivate a culture of engagement. We have four staff networks, a corporate EDI Team and a suite of programmes and events which aim to insert the 5 aspirations:

  1. Improving representation at senior levels of staff with disabilities, from black, Asian, and ethnic minorities background, identify as LGBTQ+ and women, through improved recruitment and leadership development
  2. Widening access (anchor institution) and employability
  3. Improving the experience of staff with disability
  4. Improving the EDI literacy and confidence of trust staff through training and development
  5. Making equalities mainstream

Date posted

02 May 2025

Pay scheme

Agenda for change

Band

Band 6

Salary

£37,338 to £44,962 a year per annum plus HCAS

Contract

Permanent

Working pattern

Full-time

Reference number

197-UT6732

Job locations

University Hospital Lewisham

Lewisham High Street

London

SE13 6LH


Job description

Job responsibilities

To support the Service Leads and other members of the senior management team in providing effective and efficient leadership for the service, assisting with the introduction of change within the service. To directly deliver or facilitate the delivery of training programmes for clinical engineering personnel within the Trust, ensuring training files are maintained and assisting to develop and maintain and electronic data base. To provide monthly staff progress and training reports to the senior management team. To develop and maintain electronic data bases to support the departments QMS and to provide detailed information to the department and its customers to include such things as throughput analysis, breach and non-conformance reports. To act as the link person on Quality issues between the clinical engineering and its customers. To be the administrator for the QMS and associated paperwork ensuring continued compliance; To provide the Trusts clinical engineering department with an annual audit programme and to ensure that the facilities are audited in accordance with this programme. Prepare and circulate Performance Indicator data in relation to the QMS, the departments and their customers; To assist colleagues by developing, managing and up keeping electronic records to support clinical engineering. To develop, update and maintain clinical governance information relating to the service. To maintain accurate and legible records of all changes to ISO 13485 and the databases. Responsible for the delivery of identified quality and service improvement projects or development programmes that contribute to the modernisation of Clinical Engineering. Deal with and respond to any day-to-day issues concerning the ISO 13485 and database to ensure smooth running of the department. To attend and participate in Departmental Meetings and to present complex reports to the senior management team and the department as and when required. To identify and lead change concerning ISO and the department databases. Monitor & maintain performance targets for Clinical Engineering and produce & present Key Performance Indicator (KPI) reports to ward managers and other senior managers monthly. To perform other tasks & duties which may be required by the line manager.Planning and Organisation Prepare training programmes for all Clinical Engineering personnel and organise ad-hoc training sessions in conjunction with senior personnel and ensure that key training objectives are met. Produce and implement audit programme for clinical engineering facilities ensuring that key personnel are available. Take overall responsibility for a 6 monthly Management Review Meeting and the associated documentation.Analysis and Judgement Provide complex performance data relating to the QMS to be circulated within the departments and its users; Analyse the data collected to monitor trends in performance, activity, etc, and provide reports to the senior management team to assist with service planning and development.Communication & Partnerships To be the named link person for the departments on all issues connected to the Quality Management System and to ensure that feedback is given to the senior management team; To be responsible for liaising with external agencies on all aspects relating to training and Quality; To cascade information relating to the QMS to all clinical engineering personnel and customers where appropriate; To represent the department at meetings on matters relating to the QMS.Governance To record, review and report actual or potential non-conformances within the scope of the clinical engineering and the service it provides. To monitor conformance of clinical engineering to ensure compliance with Medical Devices Directive and relevant ISO standards. Maintain accurate, complete, and timely records of all work on the ISO 13485 and Clinical Engineering electronic record systems and ensure technicians are compliant.

Quality Management System & Audit To manage the QMS system for the Trusts clinical engineering department ensuring continued compliance with the Policy & Procedure Manual ensuring non-conformances are brought to the attention of the senior management team and addressed immediately. To ensure all documentation relating to the QMS is managed efficiently and in compliance with the Policy and Procedure Manual; To provide continuous audit of the facilities and their associated processes; To quality audit staffs work and investigate and solve non-conformities within tight time parameters. To work with Trust IT department to ensure that the departments Database and locker software is functioning and report issues as they arise. To use the QMS to ensure continuous service improvements in the department are implemented; To advise of and assist with the implementation of procedural changes.

Work force Managed by the Deputy Head of Clinical Devices, the post-holder prioritises and manages own workload in accordance with departmental procedures and service demands. To work with all staff within Clinical Engineering to ensure the implementation and the ongoing updating of ISO 13485.

To help induct new staff into the department, both substantive and bank/agency in the use of the QMS and department database. To work unsupervised, reporting at defined periods on all aspects of quality and production of the department. Contribute to departmental policies and see that departmental policies are implemented and compliance measured; To take part in regular meetings with the Clinical Engineering senior management as required to review performance and work issues, and to agree and report on work aims and objectives and progress against these. Act as a positive and flexible member of the Clinical Engineering team, contributing to the achievement of team goals, and contributing to team meetings.

Financial To be aware for budgetary restraints when managing the day-to-day resource needs of the department, both pay and non-pay; Raise requisitions/orders for supplies for the department as necessary; Work with the Trust Procurement department to ensure consumable products are sourced at a competitive price and reviewed frequently with Procurement on a planned basis. To engage and manage the contribution of external specialist consultants, within an allocated budget. To manage licence renewals and associated costs.

General Post-holder will be expected to work periodically with Supervisors and Technicians in the various areas within the department and will therefore be exposed to body fluids and tissues; The work load will be planned with some periodic short notice changes to work load and frequent interruption; High levels of concentration will be required when preparing reports and analysing data from the QMS. This may be interrupted occasionally by other competing priorities; Approximately 50% of each shift will be desk based, using a PC. Whilst it isnt envisaged that the post will be subjected to hostility, there may be infrequent discussions with Clinical Engineering service users experiencing high levels of stress (e.g. lack of or missing equipment), therefore diplomacy and tact will be required. Handle heavy (>25kg) and high value equipment (up to £100k) To maintain complete and accurate records of all work on electronic data systems, ensuring that data is entered in a timely manner as directed so that records are, as far as possible, always up to date. To maintain personal training records and professional competency. Keep up to date with changes in regulations and best practice within Clinical Engineering. To be responsible for making available the Departments data base system, currently called Equip, and maintaining and supporting this to provide an asset data base, a contract, job and invoice management system, and a medical equipment training records system. To work with people involved in the various aspects of the data base system to ensure the accuracy of the data, and to actively monitor the data quality and volume and communicate with users and Section Heads to maintain the standards. The postholder will be responsible for appropriate escalation of issues which they are unable to resolve. To work with users to understand their needs, and to specify this to the software developer if further functions are needed, and to manage the upgrade process. To ensure the security of the data through backup and restore procedures, and to work with the IT department to ensure that the hardware and backup support is adequate. To support the training of users within and outside the Department, to support access to the system, and use of the system. To ensure that the system is available through the intranet, and that users are supported. To support users in developing search scripts, or other customisation that they may need from time-to-time, and to produce reports and statistics as required by the Senior Clinical Engineering Team. To carry out any other duties deemed necessary by the Senior Clinical Engineering Team that are appropriate for the grade to ensure the appropriate levels of service are maintained by the department. The duties within this Job Description are intended as a guideline only and may be amended from time to time, following consultation with the post holder.

Job description

Job responsibilities

To support the Service Leads and other members of the senior management team in providing effective and efficient leadership for the service, assisting with the introduction of change within the service. To directly deliver or facilitate the delivery of training programmes for clinical engineering personnel within the Trust, ensuring training files are maintained and assisting to develop and maintain and electronic data base. To provide monthly staff progress and training reports to the senior management team. To develop and maintain electronic data bases to support the departments QMS and to provide detailed information to the department and its customers to include such things as throughput analysis, breach and non-conformance reports. To act as the link person on Quality issues between the clinical engineering and its customers. To be the administrator for the QMS and associated paperwork ensuring continued compliance; To provide the Trusts clinical engineering department with an annual audit programme and to ensure that the facilities are audited in accordance with this programme. Prepare and circulate Performance Indicator data in relation to the QMS, the departments and their customers; To assist colleagues by developing, managing and up keeping electronic records to support clinical engineering. To develop, update and maintain clinical governance information relating to the service. To maintain accurate and legible records of all changes to ISO 13485 and the databases. Responsible for the delivery of identified quality and service improvement projects or development programmes that contribute to the modernisation of Clinical Engineering. Deal with and respond to any day-to-day issues concerning the ISO 13485 and database to ensure smooth running of the department. To attend and participate in Departmental Meetings and to present complex reports to the senior management team and the department as and when required. To identify and lead change concerning ISO and the department databases. Monitor & maintain performance targets for Clinical Engineering and produce & present Key Performance Indicator (KPI) reports to ward managers and other senior managers monthly. To perform other tasks & duties which may be required by the line manager.Planning and Organisation Prepare training programmes for all Clinical Engineering personnel and organise ad-hoc training sessions in conjunction with senior personnel and ensure that key training objectives are met. Produce and implement audit programme for clinical engineering facilities ensuring that key personnel are available. Take overall responsibility for a 6 monthly Management Review Meeting and the associated documentation.Analysis and Judgement Provide complex performance data relating to the QMS to be circulated within the departments and its users; Analyse the data collected to monitor trends in performance, activity, etc, and provide reports to the senior management team to assist with service planning and development.Communication & Partnerships To be the named link person for the departments on all issues connected to the Quality Management System and to ensure that feedback is given to the senior management team; To be responsible for liaising with external agencies on all aspects relating to training and Quality; To cascade information relating to the QMS to all clinical engineering personnel and customers where appropriate; To represent the department at meetings on matters relating to the QMS.Governance To record, review and report actual or potential non-conformances within the scope of the clinical engineering and the service it provides. To monitor conformance of clinical engineering to ensure compliance with Medical Devices Directive and relevant ISO standards. Maintain accurate, complete, and timely records of all work on the ISO 13485 and Clinical Engineering electronic record systems and ensure technicians are compliant.

Quality Management System & Audit To manage the QMS system for the Trusts clinical engineering department ensuring continued compliance with the Policy & Procedure Manual ensuring non-conformances are brought to the attention of the senior management team and addressed immediately. To ensure all documentation relating to the QMS is managed efficiently and in compliance with the Policy and Procedure Manual; To provide continuous audit of the facilities and their associated processes; To quality audit staffs work and investigate and solve non-conformities within tight time parameters. To work with Trust IT department to ensure that the departments Database and locker software is functioning and report issues as they arise. To use the QMS to ensure continuous service improvements in the department are implemented; To advise of and assist with the implementation of procedural changes.

Work force Managed by the Deputy Head of Clinical Devices, the post-holder prioritises and manages own workload in accordance with departmental procedures and service demands. To work with all staff within Clinical Engineering to ensure the implementation and the ongoing updating of ISO 13485.

To help induct new staff into the department, both substantive and bank/agency in the use of the QMS and department database. To work unsupervised, reporting at defined periods on all aspects of quality and production of the department. Contribute to departmental policies and see that departmental policies are implemented and compliance measured; To take part in regular meetings with the Clinical Engineering senior management as required to review performance and work issues, and to agree and report on work aims and objectives and progress against these. Act as a positive and flexible member of the Clinical Engineering team, contributing to the achievement of team goals, and contributing to team meetings.

Financial To be aware for budgetary restraints when managing the day-to-day resource needs of the department, both pay and non-pay; Raise requisitions/orders for supplies for the department as necessary; Work with the Trust Procurement department to ensure consumable products are sourced at a competitive price and reviewed frequently with Procurement on a planned basis. To engage and manage the contribution of external specialist consultants, within an allocated budget. To manage licence renewals and associated costs.

General Post-holder will be expected to work periodically with Supervisors and Technicians in the various areas within the department and will therefore be exposed to body fluids and tissues; The work load will be planned with some periodic short notice changes to work load and frequent interruption; High levels of concentration will be required when preparing reports and analysing data from the QMS. This may be interrupted occasionally by other competing priorities; Approximately 50% of each shift will be desk based, using a PC. Whilst it isnt envisaged that the post will be subjected to hostility, there may be infrequent discussions with Clinical Engineering service users experiencing high levels of stress (e.g. lack of or missing equipment), therefore diplomacy and tact will be required. Handle heavy (>25kg) and high value equipment (up to £100k) To maintain complete and accurate records of all work on electronic data systems, ensuring that data is entered in a timely manner as directed so that records are, as far as possible, always up to date. To maintain personal training records and professional competency. Keep up to date with changes in regulations and best practice within Clinical Engineering. To be responsible for making available the Departments data base system, currently called Equip, and maintaining and supporting this to provide an asset data base, a contract, job and invoice management system, and a medical equipment training records system. To work with people involved in the various aspects of the data base system to ensure the accuracy of the data, and to actively monitor the data quality and volume and communicate with users and Section Heads to maintain the standards. The postholder will be responsible for appropriate escalation of issues which they are unable to resolve. To work with users to understand their needs, and to specify this to the software developer if further functions are needed, and to manage the upgrade process. To ensure the security of the data through backup and restore procedures, and to work with the IT department to ensure that the hardware and backup support is adequate. To support the training of users within and outside the Department, to support access to the system, and use of the system. To ensure that the system is available through the intranet, and that users are supported. To support users in developing search scripts, or other customisation that they may need from time-to-time, and to produce reports and statistics as required by the Senior Clinical Engineering Team. To carry out any other duties deemed necessary by the Senior Clinical Engineering Team that are appropriate for the grade to ensure the appropriate levels of service are maintained by the department. The duties within this Job Description are intended as a guideline only and may be amended from time to time, following consultation with the post holder.

Person Specification

Qualifications & Training

Essential

  • Minimum of degree level In Electrical or Electronics or equivalent acquired through training and experience
  • Diploma in formal Quality System management or equivalent training and work experience.
  • Current Driving Licence.

Desirable

  • Auditor Certificate ISO9001:2000

Experience

Essential

  • Experience in managing a formal Quality System, and in producing procedures within the Quality System
  • Experience managing a complex data base or other complex software system used by others, with experience of supporting users and system configuration.

Desirable

  • Specific experience of BS13485 Experience of conducting audits in accordance with ISO 9001:2000 and 13485

Knowledge & Skills

Essential

  • o Computer literacy (Word processing, Spreadsheets, Database, Maintenance management systems)
  • o Appreciation of current software packages.
  • o Good working knowledge of a broad range of electronic engineering principles and practical applications.
  • Good working knowledge of specialist areas of medical equipment management.

Desirable

  • Auditing skills
Person Specification

Qualifications & Training

Essential

  • Minimum of degree level In Electrical or Electronics or equivalent acquired through training and experience
  • Diploma in formal Quality System management or equivalent training and work experience.
  • Current Driving Licence.

Desirable

  • Auditor Certificate ISO9001:2000

Experience

Essential

  • Experience in managing a formal Quality System, and in producing procedures within the Quality System
  • Experience managing a complex data base or other complex software system used by others, with experience of supporting users and system configuration.

Desirable

  • Specific experience of BS13485 Experience of conducting audits in accordance with ISO 9001:2000 and 13485

Knowledge & Skills

Essential

  • o Computer literacy (Word processing, Spreadsheets, Database, Maintenance management systems)
  • o Appreciation of current software packages.
  • o Good working knowledge of a broad range of electronic engineering principles and practical applications.
  • Good working knowledge of specialist areas of medical equipment management.

Desirable

  • Auditing skills

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.

Employer details

Employer name

Lewisham and Greenwich NHS Trust

Address

University Hospital Lewisham

Lewisham High Street

London

SE13 6LH


Employer's website

https://www.lewishamandgreenwich.nhs.uk/ (Opens in a new tab)


Employer details

Employer name

Lewisham and Greenwich NHS Trust

Address

University Hospital Lewisham

Lewisham High Street

London

SE13 6LH


Employer's website

https://www.lewishamandgreenwich.nhs.uk/ (Opens in a new tab)


For questions about the job, contact:

EBME Manager

Andrew Jarvis

andrew.jarvis@nhs.net

07884408938

Date posted

02 May 2025

Pay scheme

Agenda for change

Band

Band 6

Salary

£37,338 to £44,962 a year per annum plus HCAS

Contract

Permanent

Working pattern

Full-time

Reference number

197-UT6732

Job locations

University Hospital Lewisham

Lewisham High Street

London

SE13 6LH


Supporting documents

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