Job summary
An exciting opportunity has arisen for a Medical Device Safety Officer to join the Governance Support Unit.
You will act as the Trust Medical Devices Safety Officer (MDSO) ensuring the Trust responds effectively to all manufacturer and MHRA device safety notices.
As the MDSO your key role is to promote reporting and learning and safe use of medical devices across the organisation and be the main expert resource in this practice area. In addition to improving the quality of reporting, the MDSO would serve as the 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 will be the 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 will Lead on the investigation of serious device related incidents.
In conjunction with the head of clinical engineering you will lead medical device governance for the Trust creating a programme of medical device safety improvement. You will also provide reports in relation to the safe use of medical devices to the Medical Devices Oversight Group.
You will oversee the Creation and maintaining an effective medical device inventory and work with the Clinical Engineering manager in maintaining the quality accreditation and improving data management within Clinical Engineering.
Main duties of the job
- Active membership of the National Medical Device Safety Network.
- Provide authoritative and reliable advice in supporting healthcare staff in the safe use of medical devices.
- Responsible for executing any device recalls or safety enhancements issued either by the manufacturers or the MHRA.
- Be responsible for reporting Medical Device incidents to the MHRA via the Yellow Card system.
- Provide quarterly reports on Incidents, Risks and Safety for devices to medical device oversight group.
- Responsible for assurance relating to agreed Key Performance Indicators.
- Work with the trust Medicines Safety Officer where appropriate.
- Communicate to individuals, medical equipment information which will include policy changes, new policies, guidelines and regulations.
- Manage and encourage medical device incident reporting in the organisation to improve reporting and learning from medical device incidents.
- Be an active member of the Medical Device Oversight Group, providing safety reports on the use of medical devices.
- Be an active member of the Clinical Procurement Group and provide scrutiny on the safety of proposed new medical devices being submitted to eth group for trial approval.
About us
All new colleagues can expect to receive a warm and friendlyWirral welcome from the very first time they make contact withus. We are described as "competent and caring staff" by ourpatients.
Wirral University Teaching Hospital NHS Foundation Trust issituated on The Wirral peninsula which has a stunning coastlineand beautiful countryside surroundings, with great activities forits residents.
We are one of the largest and busiest acute Trusts in the NorthWest of England, comprising of the Wirral's only EmergencyDepartment. We provide a high quality range of acute careservices and employ over 6,000 staff, who serve a population ofapproximately 400,000 people across Wirral, Ellesmere Port,Neston, North Wales and the wider North West footprint.We have approximately 855 beds trust-wide and our financialturnover is in excess of £337m.
The Wirral is easily accessible with excellent transport linksincluding motorway, train, bus or ferry and within easy reach tothe major cities of Liverpool, Chester and Manchester as wellas neighbouring North Wales
Job description
Job responsibilities
Please see Job overview & attached Job description for further information about the Medical Device Safety Officer position available with WUTH.
Job description
Job responsibilities
Please see Job overview & attached Job description for further information about the Medical Device Safety Officer position available with WUTH.
Person Specification
Qualifications, Specific Experince & Training
Essential
- BSc or HND in a relevant, healthcare, scientific or engineering subject.
- Master's degree (or equivalent level combination of post-graduate study and experience) in medical device, quality assurance or other healthcare technology.
- Evidence of continuing professional development in relation to medical device safety Possess suitable qualifications and experience to provide professional advice relating to medical device management, legislation and regulatory compliance.
Desirable
- Membership of a relevant professional body.
- Project management qualification, e.g. PRINCE 2.
Knowledge & Skills
Essential
- Leadership skills to support staff working with a wide range of medical equipment.
- Understanding of the principles of risk and incident management and the use of SEIPS Investigation - with a high level of understanding of the patient and staff safety risks that may arise from equipment failure.
- Expert technical knowledge in medical equipment technologies, able to investigate investigation of clinical Incidents.
- Sound knowledge of statutory, regulatory and governance obligations relating to medical equipment management, acquisition, usage and upkeep.
- Have an advanced level of IT knowledge.
- Ability to manage stressful situations sympathetically and in a supportive manner.
- Show aptitude for working under pressure in a busy unit.
- Ability to interpret national guidance and legislation and demonstrable experience in developing and implementing policy across a complex and geographically large healthcare environment.
- Experience of undertaking risk assessments on medical devices and have ability to find novel solutions to minimise risk where appropriate.
- Broad knowledge of medical device operational management.
- Experience in research and development, so able to advise on the design, implementation and analysis of product trials and reviews, using good research principles.
Desirable
- 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 in operation and function of patient-critical equipment and techniques in healthcare.
- Experience in the use and operation of a quality management system such as ISO 9001:2000.
Personal Attributes
Essential
- Provide and receive highly complex, sensitive and contentious information, negotiate with senior stakeholders on difficult and controversial issues, and present complex and sensitive information.
- Negotiate on difficult and very complex and detailed issues.
- Confident and self-motivated.
- Collaborative with high level of person integrity.
- Ability to work on own initiative.
Person Specification
Qualifications, Specific Experince & Training
Essential
- BSc or HND in a relevant, healthcare, scientific or engineering subject.
- Master's degree (or equivalent level combination of post-graduate study and experience) in medical device, quality assurance or other healthcare technology.
- Evidence of continuing professional development in relation to medical device safety Possess suitable qualifications and experience to provide professional advice relating to medical device management, legislation and regulatory compliance.
Desirable
- Membership of a relevant professional body.
- Project management qualification, e.g. PRINCE 2.
Knowledge & Skills
Essential
- Leadership skills to support staff working with a wide range of medical equipment.
- Understanding of the principles of risk and incident management and the use of SEIPS Investigation - with a high level of understanding of the patient and staff safety risks that may arise from equipment failure.
- Expert technical knowledge in medical equipment technologies, able to investigate investigation of clinical Incidents.
- Sound knowledge of statutory, regulatory and governance obligations relating to medical equipment management, acquisition, usage and upkeep.
- Have an advanced level of IT knowledge.
- Ability to manage stressful situations sympathetically and in a supportive manner.
- Show aptitude for working under pressure in a busy unit.
- Ability to interpret national guidance and legislation and demonstrable experience in developing and implementing policy across a complex and geographically large healthcare environment.
- Experience of undertaking risk assessments on medical devices and have ability to find novel solutions to minimise risk where appropriate.
- Broad knowledge of medical device operational management.
- Experience in research and development, so able to advise on the design, implementation and analysis of product trials and reviews, using good research principles.
Desirable
- 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 in operation and function of patient-critical equipment and techniques in healthcare.
- Experience in the use and operation of a quality management system such as ISO 9001:2000.
Personal Attributes
Essential
- Provide and receive highly complex, sensitive and contentious information, negotiate with senior stakeholders on difficult and controversial issues, and present complex and sensitive information.
- Negotiate on difficult and very complex and detailed issues.
- Confident and self-motivated.
- Collaborative with high level of person integrity.
- Ability to work on own initiative.
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).
