Job summary This job advert will close as soon as sufficient applications have been received. Please apply for this job as soon as you can, if interested The postholder is expected to continue to implement and embed a developing Quality Management System (QMS) within the staff and line management structure of the Adults and Specialist Rehabilitation Division, (ASRD). The post holder will have overall managerial responsibility for the structure of the QMS which will cover all aspects of regulatory performance and accreditation requirements. However the responsibility for ensuring staff participation in the system lies with the post of the Lead Clinical Scientist and the subordinate line management structures. The QMS needs to comply with ISO 13485 for the creation of in-house manufactured and custom-made Medical Devices for supply to patients referred to the following services; Regional Posture and Mobility Service, Access to Communication and Technology, Birmingham Wheelchair Service and Mechanical Workshop. The postholder will be required to liaise closely with the team leaders and line managers of the relevant sections of the ASRD division in order to engage them in the process of embedding the Quality Management ethos within their day to day work. The Postholder will lead and provide advice in the highly specialised area of quality management to ensure successful compliance with the various accrediting and auditing bodies through the setting of high-level performance standards. Main duties of the job Maintain and develop a divisional Quality Management System to achieve regulatory compliance and EN ISO 13485 accreditation, managing change across varied working practices. Provide quality assurance to teams designing and manufacturing in-house or custom medical devices, ensuring patient safety and clinical effectiveness. Interpret and apply ISO 13485 within existing structures and processes, ensuring regulatory compliance and effective audit demonstration. Develop and review an ASRD quality improvement plan aligned to Trust strategy, reviewing progress monthly. Maintain and harmonise high-level quality policies and procedures to meet statutory, regulatory and accreditation requirements. Develop and implement effective Records and Archiving Policies aligned with NHS, government and local requirements. Establish and support robust internal audit systems, ensuring audits are delivered, followed up and reported. Advise senior managers on quality concerns identified through audit that may risk patient safety. Implement competency-based appraisal to identify learning and development needs of technical, clinical and scientific staff. Identify and support staff training and development, coordinating internal and external provision. Maintain awareness of national NHS strategy to support service improvement. Develop and empower staff to perform to high standards and drive innovation. About us Be Part of Our Team Birmingham Community Healthcare NHS Foundation Trust (BCHC) has more than 5000 staff working across Birmingham and the West Midlands in a wide range of community nursing and specialist healthcare roles. BCHC delivers over 100 clinical services, in people's homes, health centres, clinics and inpatient facilities. We deliver a wide range of services for children, young people, parents and families as well as adults and community services, two community hospitals, services for people with learning disabilities, the internationally recognised West Midlands Rehabilitation Centre and one of Europe's leading Dental Hospitals and School of Dentistry. We deliver all of this with a commitment to integrated, personalised care that is rooted in our local communities. We have an ambition to deliver outstanding, integrated care as one of the key NHS providers in the West Midlands. If you want to 'Be Part of Our Team' and work with a Foundation Trust which is continuously striving for better care and healthier communities, we want to hear from you. IMPORTANT Please ensure you check your Trac account regularly as this is how we will communicate with you during the shortlisting and selection process. Please ensure all sections of the application form are completed fully. Please particularly ensure that you provide full details of all referees including business email address, telephone contact details and postal address Job description Job responsibilities For further details on the main responsibilities, please see the attached job description and person specification. Job description Job responsibilities For further details on the main responsibilities, please see the attached job description and person specification. Person Specification Qualifications Essential Degree or equivalent in relevant subjects Membership of the RCT as Clinical Technologist Desirable Relevant Quality Management qualification or equivalent Member of relevant professional body Experience Essential Extensive practical experience post degree working in the field of Clinical Sciences - including practical experience working with quality systems within those environments. Experience of leading quality management projects Experience of change management Experience in conducting and participating in internal audit Understanding or experience of software/IT/Engineering development processes Desirable Significant experience in the application of the Medical Devices Directive and knowledge of its likely Future replacements Experience of managing a budget line within an NHS environment. Person Specification Qualifications Essential Degree or equivalent in relevant subjects Membership of the RCT as Clinical Technologist Desirable Relevant Quality Management qualification or equivalent Member of relevant professional body Experience Essential Extensive practical experience post degree working in the field of Clinical Sciences - including practical experience working with quality systems within those environments. Experience of leading quality management projects Experience of change management Experience in conducting and participating in internal audit Understanding or experience of software/IT/Engineering development processes Desirable Significant experience in the application of the Medical Devices Directive and knowledge of its likely Future replacements Experience of managing a budget line within an NHS environment. 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. 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.. UK Registration Applicants must have current UK professional registration. For further information please see 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. 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. 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.. UK Registration Applicants must have current UK professional registration. For further information please see Employer details Employer name Birmingham Community Healthcare NHS FT Address West Midlands Rehabilitation Centre Oak Tree Lane Birmingham B29 6JA United Kingdom Employer's website