Job summary
An exciting opportunity has arisen for a motivated and enthusiastic Band 8A Medical Devices Safety and Quality Officer to join the dedicated management team within our Clinical Engineering Department.
This is a senior post working as part of the Clinical Engineering management team with a leading role in the evaluation and investigation of safety alerts and adverse incidents involving medical devices.
The Clinical Engineering department is a highly-quality technical and scientific service in the field of Medical Device management providing medical device management services in terms of procurement, repair, calibration and maintenance to a wide range of diagnostic and therapeutic medical equipment in the Cambridge University Hospitals NHS Foundation Trust. It is the responsibility of Clinical Engineering to ensure equipment operates effectively and safely with a minimum of downtime. Clinical equipment covered incorporates electrical, electronic, mechanical, computer software and medical gas systems. The department works to ISO 9001 and ISO 13485 quality standards and is responsible for the management in excess of 60,000 medical devices used across the hospital and in the community throughout East Anglia.
Main duties of the job
You will work closely with the Technical Services Manager to lead on the evaluation and investigation of safety alerts and adverse incidents involving medical devices, and the reporting and management of them. You will also have a central role in ensuring quality, safety, conformity assurance, best practice and continual improvement of Clinical Engineering services, supported by a competency management and training framework for the development of technical staff.
The MDSQO's key role is to promote reporting and learning and safe use of medical devices across their organisation and be the main expert resource in this practice area. In addition to improving the quality of reporting, the MDSQO will serve as an essential link between the identification and implementation of (local and national) medical device safety initiatives and the daily operations to improve the safe use of medical devices.
You are responsible for providing leadership to Clinical Engineering and the Medical Device Management Group staff and advice to the Trust on matters relating to device safety, user competence and patient experience.
The Quality Officer's aim is to ensure that the product or service Clinical Engineering provides is fit for purpose, is consistent and meets both external and internal requirements. This includes legal compliance and customer expectations.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 13,000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description
Job responsibilities
The Quality Officer will monitor and advise on the performance of the quality management system, produce data and report on performance, measuring against set standards.
You will have a good working knowledge of IT systems and associated software packages as well as healthcare IT systems. Experience of medical terminology is desirable but not essential.
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Due to Home Office immigration rules, a full time permanent vacancy cannot be filled by individuals on a Student visa. Therefore, please be advised that if you are a Student visa holder, we will not be able to offer you a full time permanent contract unless you have:- applied for a Graduate visa- or you will have successfully completed your course and have applied for a Graduate visa before the anticipated start date of your employment- or the Trust has agreed that they will Sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment
This vacancy will close at midnight on 26th August 2024
Interviews are due to be held on 9th September 2024
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
The Quality Officer will monitor and advise on the performance of the quality management system, produce data and report on performance, measuring against set standards.
You will have a good working knowledge of IT systems and associated software packages as well as healthcare IT systems. Experience of medical terminology is desirable but not essential.
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Due to Home Office immigration rules, a full time permanent vacancy cannot be filled by individuals on a Student visa. Therefore, please be advised that if you are a Student visa holder, we will not be able to offer you a full time permanent contract unless you have:- applied for a Graduate visa- or you will have successfully completed your course and have applied for a Graduate visa before the anticipated start date of your employment- or the Trust has agreed that they will Sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment
This vacancy will close at midnight on 26th August 2024
Interviews are due to be held on 9th September 2024
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- Degree in relevant subject.
- MSc in Biomedical Engineering [or equivalent]
- Eligible for Registration as a Clinical Technologist
Desirable
- Membership of a relevant professional body
- Post Graduate Quality or Management Qualification
Experience
Essential
- Experience in operation and function of patient-critical equipment and techniques in healthcare.
- Extensive experience in interpreting different situations and judging measures required to ensure appropriate use of technology.
- Extensive practical experience in electro medical engineering workshop practices and techniques, equivalent of independent practice including preventative maintenance, servicing, inspection, repair, calibration, quality control, safety, acceptance testing and procurement
- Experience of undertaking risk assessments on medical devices and have ability to find novel solutions to minimise risk where appropriate
- Experience in the use and operation of a quality management system such as ISO 9001:2000
- Broad knowledge of medical device operational management
Desirable
- Specialist training on the maintenance and repair of a range of medical devices.
Knowledge
Essential
- Broad knowledge of electronic workshop practice and computer systems.
- Broad knowledge of medical device operation and management.
- Advanced knowledge of all aspects of Clinical Engineering.
- High level of understanding of the impact of all aspects of equipment use and provision on clinical service delivery
- Advanced knowledge of relevant legislation, national standards, professional and other guidelines [e.g. ISO 9001 2000, 13485:2012, BSI standards , RIDDOR, MDA/MHRA guidance, Health and Safety, COSHH]
- High level of understanding of patient and staff risks arising from equipment failure
Desirable
- Operation and use of equipment management database(s)
Skills
Essential
- Able to exercise own initiative when dealing with issues within own specialist area of competence.
- Able to deal with complex and unpredictable situations
- Able to deal with occasional distressing circumstances when working in clinical areas (e.g. when visiting wards and theatres fault finding on patient connected equipment).
- Able to supervise the work of others, if appropriate
- Able to prioritise and manage own work
- Able to use SQL, Excel, Word, Access, PowerPoint etc to set up documents and spreadsheets, extract information, calculate results and prepare reports.
- Possess an attention to detail and ability to work on complex data to produce accurate information management systems
- Possess good negotiation and influencing skills
Desirable
- Able to communicate complex information across professional boundaries (e.g. incident analysis).
- Able to deliver teaching and training on complex equipment to other professional groups (e.g. train staff in medical device use).
- Able to concentrate frequently when subject to unpredictable working patterns.
- Project management methodology
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Knowledge of employment procedures and practices
- Understanding of the anxiety, distress and confusion of some patients and relatives
Person Specification
Qualifications
Essential
- Degree in relevant subject.
- MSc in Biomedical Engineering [or equivalent]
- Eligible for Registration as a Clinical Technologist
Desirable
- Membership of a relevant professional body
- Post Graduate Quality or Management Qualification
Experience
Essential
- Experience in operation and function of patient-critical equipment and techniques in healthcare.
- Extensive experience in interpreting different situations and judging measures required to ensure appropriate use of technology.
- Extensive practical experience in electro medical engineering workshop practices and techniques, equivalent of independent practice including preventative maintenance, servicing, inspection, repair, calibration, quality control, safety, acceptance testing and procurement
- Experience of undertaking risk assessments on medical devices and have ability to find novel solutions to minimise risk where appropriate
- Experience in the use and operation of a quality management system such as ISO 9001:2000
- Broad knowledge of medical device operational management
Desirable
- Specialist training on the maintenance and repair of a range of medical devices.
Knowledge
Essential
- Broad knowledge of electronic workshop practice and computer systems.
- Broad knowledge of medical device operation and management.
- Advanced knowledge of all aspects of Clinical Engineering.
- High level of understanding of the impact of all aspects of equipment use and provision on clinical service delivery
- Advanced knowledge of relevant legislation, national standards, professional and other guidelines [e.g. ISO 9001 2000, 13485:2012, BSI standards , RIDDOR, MDA/MHRA guidance, Health and Safety, COSHH]
- High level of understanding of patient and staff risks arising from equipment failure
Desirable
- Operation and use of equipment management database(s)
Skills
Essential
- Able to exercise own initiative when dealing with issues within own specialist area of competence.
- Able to deal with complex and unpredictable situations
- Able to deal with occasional distressing circumstances when working in clinical areas (e.g. when visiting wards and theatres fault finding on patient connected equipment).
- Able to supervise the work of others, if appropriate
- Able to prioritise and manage own work
- Able to use SQL, Excel, Word, Access, PowerPoint etc to set up documents and spreadsheets, extract information, calculate results and prepare reports.
- Possess an attention to detail and ability to work on complex data to produce accurate information management systems
- Possess good negotiation and influencing skills
Desirable
- Able to communicate complex information across professional boundaries (e.g. incident analysis).
- Able to deliver teaching and training on complex equipment to other professional groups (e.g. train staff in medical device use).
- Able to concentrate frequently when subject to unpredictable working patterns.
- Project management methodology
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Knowledge of employment procedures and practices
- Understanding of the anxiety, distress and confusion of some patients and relatives
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.
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).
Additional information
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.
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).