About this role
Job summary
The Clinical Engineering Department at Cardiff and Vale UHB are excited to be the first department of its kind in Wales to be recruiting for a full-time Medical Device Safety Officer (MDSO).
This role will give the successful applicant an excellent opportunity to improve patient safety and join a team who are passionate about effective and safe medical equipment management.
Main duties of the job
Ensuring effective reporting and response to adverse incidents involving medical devices, and that lessons are learnt and shared throughout the organisation.
Performing and leading investigations into a broad range of patient safety incidents involving medical devices.
The post-holder will also play a key role in the management of medical device safety alerts including their assessment, distribution and support for identified safety actions.
Interpreting legislation, national guidance and industry best practice into UHB policy and management processes to ensure national initiatives and required changes are delivered.
About us
Cardiff and Vale University Health Board is one of the largest Integrated Health Boards in the UK, employing over 17,000 staff, providing over 100 specialist services. Working across 6 hospital sites, we have a diverse range of career opportunities to offer. Serving over 500,000 people living in Cardiff and the Vale, we are focussed on the health and care needs of our local population whilst working with our partners to develop regional services. Together we are committed to improving health outcomes for everyone, delivering excellent care and support.
Our mission is "Living Well, Caring Well, Working Together", and our vision is that every person's chance of leading a healthy life should be equal. Our 10-year transformation and improvement strategy, Shaping Our Future Wellbeing, is our chance to work collaboratively with the public and our workforce to make our health board more sustainable for the future.
Job description Job responsibilities
You will be able to find a full Job description and Person Specification attached within the supporting documents.
The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.
Person Specification
Qualifications Essential
Degree qualification in relevant subject. (or HNC/HND equivalent with apprenticeship) Extensive additional theoretical knowledge acquired through CPD (professional short courses, personal study, conferences) and professional training in relevant working environments. Professional registration (eg: Incorporated Engineer; Registered Clinical Technologist, HCPC, etc.). Masters level qualification (equivalent experience).
Experience Essential
Extensive professional experience of hospital clinical engineering services, with a broad knowledge & experience of medical technology and its applications. Extensive specialist knowledge and practical experience in medical engineering workshop services at senior level, with expert understanding of best practices relating to to equipment commissioning, assurance, maintenance, repair, and decommissioning activities. Sound knowledge of medical device governance in healthcare environments; knowledge of regulatory framework and auditing standards (CQC, MHRA, HSE, MDR, etc.). Considerable experience of medical device incident investigations and safety alert management. Sound knowledge & experience of risk management techniques and their application.
Desirable
Experience of competency management in practice; experience of mentoring the professional development of technical staff. Sound knowledge, and experience of its application, in the field of quality management systems and relevant standards (eg: ISO-9001, ISO-13485, etc.). Auditing experience - capable of planning, conducting and reporting audits. Work experience within project & programme environments.
Skills Essential
Advanced software user skills; (competent user of office, spreadsheet & database applications, etc.). Ability to develop professional rapport with departmental staff, managerial staff, service users and suppliers. Ability to communicate complex information across professional boundaries to a range of staff; ability to receive and process information from a similar range of professions. Ability to deal with complex and unpredictable situations and people; able to deal with difficult situations and customer anxiety in a professional manner. Ability to lead operational and project groups; good meeting management and chairing skills. Good negotiation and influencing skills, able to provide assurance and reports with credibility and integrity. Excellent documentation and reporting skills Ability to empathise with, support and guide junior staff and trainees. Ability to objectively investigate incidents and problems without prejudice or preconception, adopting an open and questioning approach with committed attention to detail. Ability to independently prioritise, analyse, and investigate complex service issues and problems; to identify root causes and resolve, ensuring that effective interventions are implemented. Ability to interpret and apply legislation / policy where there is no precedent. Ability to collect, analyse and critically interpret complex data sets and to report accordingly. Ability to plan and drive initiatives and programmes of work across the service to optimise safety management, both within own department and to support clinical departments where medical devices are used. Ability to exercise initiative and leadership when working within own area of competence and expertise. Ability to respond positively to changes in priorities and demands; and to work independently and under pressure, optimally prioritising workload.
Desirable
Ability to deliver teaching and training on medical device safety, risk management & governance to departmental staff and other professional groups. Experience of supporting clinical or scientific research projects.
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.
Certificate of Sponsorship 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).
Employer details Employer name Cardiff and Vale University Health Board
Address Field Way
Clinical Engineering, 20 Field Way
Cardiff
CF14 4HY
United Kingdom
Employer's website https://cavuhb.nhs.wales/ (Opens in a new tab)