Quality and Information Systems Manager

Lewisham and Greenwich NHS Trust, (LGT), is a community-focused provider of local and acute care, delivering high-quality services to over one million people living across the London boroughs of Lewisham, Greenwich, and Bexley. We provide whole-life care and are here to support our communities to live healthier lives as well as taking care of them when they need us the most.

Employing almost 7,500 colleagues, affectionately known as Team LGT, we provide services at Queen Elizabeth Hospital in Woolwich, University Hospital Lewisham, and at over a dozen community settings in Lewisham. We also provide some services at Queen Mary’s Hospital in Sidcup.

We have recently launched our new vision and values to mark the LGT10 – the tenth anniversary of our Trust forming in 2013. Our trust vision is to be exceptional. In the quality of our patient care; our support for colleagues; and in the difference we make through our partnerships and in our communities.

To achieve this we value Respect, Compassion, and Inclusion; Being accountable over staying comfortable; Listening over always knowing best; and Succeeding together over achieving alone. You can read more about our visions and values here

Our hospitals and community sites provide a wide range of inpatient and outpatient services, as well as emergency and planned care. The Trust is rated as “good” or “outstanding” in over three-quarters of the services inspected by the Care Quality Commission.

Every year our work includes performing 10,000 procedures in our theatres; bringing seven and a half thousand new lives into the world; carrying out 570,000 visits to patients in their homes or communities and providing emergency care for more than 300,000 patients arriving in our busy Urgent and Emergency Departments.

LGT is a centre for the education and training of medical students enrolled with King’s College London’s GKT School of Medical Education. We are a training centre for nurses, midwives and allied health professionals. We are pioneering new roles that will support the changing needs of our patients and are one of the largest employers of physician associates in the country.

We are committed to working with our partners to deliver the best outcomes for our local communities. This means playing an active role in the South East London Integrated Care System (ICS), and in formal partnerships including the South East London Acute Provider Collaborative, provider partnerships with our local mental health trusts and borough-based boards of the ICS in Bexley, Greenwich and Lewisham.

Job overview

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 [email protected], 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.

• To maintain comprehensive training records for clinical engineering personnel relating to ISO and the databases.
• To organise and co-ordinate internal/external training programmes for clinical engineering personnel.
• 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.
• 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.

Working for our organisation

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

Detailed job description and main responsibilities

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 isn’t 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 Department’s 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

• 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.

• Auditor Certificate ISO9001:2000

Experience

• 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.

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

Knowledge & Skills

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

• Auditing skills

We reserve the right to close the post before the stated closing date, please apply early. We do not contact applicants with the outcome of the shortlisting. If you have been shortlisted, you will receive an invite to an assessment day or interview.

We have a number of active staff networks including Disability, LGBT+, Multicultural Inclusion and Women’s staff networks to bring staff together and celebrate diversity across our whole workforce.

Please note, not all roles will meet the criteria for a skilled worker visa.