Job summary
We are pleased to offer an exciting opportunity to join the National Imaging Academy Wales (NIAW) team.The post holder will work alongside a multidisciplinary team of Academy Managers & Administrators, Academy Trainers, and Academy Researchers to establish and maintain a Quality Management System(s) to support the Business, Innovation & Research functions of the Academy. This will include leading the Academy to achieve ISO certification and support the creation of a formal research support programme at NIAW to facilitate research, considering principles of good clinical practices and appropriate clinical governance (study design, protocol, IRAS, REC, etc).
As well as supporting training for a variety of professions, the Imaging Academy has also established itself as a hub for innovative research and development. This unique opportunity will see the post holder use their previous experience in the quality management for the manufacture and deployment of medical devices. This is to support the Academy and the wider NHS Wales in the development and deployment of Artificial Intelligence.
The post holder will also work alongside other NHS Wales, industry, academic and research colleagues to educate, improve knowledge and increase understanding of the regulatory requirements for the manufacture of medical devices, providing valuable advice and guidance throughout innovation & research projects.
Main duties of the job
The post holder will:Be responsible for the establishment and management of a Quality Management System (QMS) and Document Control System (DCS) for NIAW training, operational, business, research, and innovation activities.
Be responsible for the establishment and management of a Quality Management System (QMS) related to Medical Devices Regulations and Artificial Intelligence (AI).
Support the commissioning of high-quality training, education, and research services in NIAW.
Support the administrative, quality assurance and regulatory functions of NIAWs Agored Cymru Centre and research programmes.
Support, motivate and develop staff within NHS Wales diagnostic imaging community, offering considered QMS advice, guidance, and services, with particular focus on research and Medical Device Regulations.
Developing improved ways of working to continually improve the quality of NIAW Training, business, and services.
Leading on and developing policies and procedures in relation to quality QM & DC.
The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.
About us
Cwm Taf Morgannwg University Health Board is part of the NHS Wales family. Our Health Board provides primary, secondary and community health and wellbeing services to around 450,000 people living in three County Boroughs: Bridgend Merthyr Tydfil, and Rhondda Cynon Taf.
We live by our core values:
- We listen, learn and improve
- We treat everyone with respect
- We all work together as one team
We are a proud local employer; around 80% of our 15000 workforce live within our region, making our staff not only our lifeblood of our organisation but of the diverse communities that we serve.
Job description
Job responsibilities
Have strong knowledge of quality assurance.
Have knowledge of Quality Standards and Regulations such as professional and/or international standards.
Have knowledge and understanding of Medical Device Directive and other standards.
Have a commitment to keep up to date with changes to clinical service practices and regulatory standards through maintaining their own professional development (CPD).
Professionally accountable for ones own practice and abide by all Academy and Host Organisations guidelines, policies, and protocols.
Lead on the undertaking of regular internal quality assurance audits and, based on the findings, provide expert information, advice, and guidance.
Have expert level competency and skills to train, direct and supervise others in QM processes.
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.
Job description
Job responsibilities
Have strong knowledge of quality assurance.
Have knowledge of Quality Standards and Regulations such as professional and/or international standards.
Have knowledge and understanding of Medical Device Directive and other standards.
Have a commitment to keep up to date with changes to clinical service practices and regulatory standards through maintaining their own professional development (CPD).
Professionally accountable for ones own practice and abide by all Academy and Host Organisations guidelines, policies, and protocols.
Lead on the undertaking of regular internal quality assurance audits and, based on the findings, provide expert information, advice, and guidance.
Have expert level competency and skills to train, direct and supervise others in QM processes.
You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac.
Person Specification
Qualifications
Essential
- BSc in appropriate subject, supplemented by additional highly developed specialist knowledge, training and work experience to Master's Level equivalency.
Desirable
- Teaching qualification at Level 3 (minimum) or relevant experience at delivery of training.
- Management/Leadership qualification.
Knowledge
Essential
- Knowledge of how to obtain CE/UKCA and MDR approval.
- Change management knowledge and skills.
Experience
Essential
- Current/recent role in quality management.
- Previous experience of managing and driving the process, ideally underpinned with engineering, data science, medical, life-sciences background.
- Previous experience of undertaking audits.
- Experience in the development, delivery and evaluation of training and development.
Desirable
- Evidence of contributing to practice development
Person Specification
Qualifications
Essential
- BSc in appropriate subject, supplemented by additional highly developed specialist knowledge, training and work experience to Master's Level equivalency.
Desirable
- Teaching qualification at Level 3 (minimum) or relevant experience at delivery of training.
- Management/Leadership qualification.
Knowledge
Essential
- Knowledge of how to obtain CE/UKCA and MDR approval.
- Change management knowledge and skills.
Experience
Essential
- Current/recent role in quality management.
- Previous experience of managing and driving the process, ideally underpinned with engineering, data science, medical, life-sciences background.
- Previous experience of undertaking audits.
- Experience in the development, delivery and evaluation of training and development.
Desirable
- Evidence of contributing to practice development
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).
