Band 7 Quality Manager

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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 postholder will have overall managerial responsibility for the structure of the QMS covering all aspects of regulatory performance and accreditation requirements.

The QMS must comply with ISO 13485 for the creation of in house manufactured and custom made medical devices supplied to the following services: Regional Posture and Mobility Service, Access to Communication and Technology, Birmingham Wheelchair Service and Mechanical Workshop.

The postholder will liaise closely with team leaders and line managers of the relevant sections of the ASRD division to embed the Quality Management ethos within their day to day work. The postholder will lead and advise in the highly specialised area of quality management to ensure successful compliance with accrediting and auditing bodies through the setting of high level performance standards.

Main duties of the job

Maintain and develop a divisional QMS 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.

Qualifications

• Degree or equivalent in relevant subjects
• Membership of the RCT as Clinical Technologist
• Relevant quality management qualification or equivalent
• Member of relevant professional body

Experience

• 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
• 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

In accordance with UK Home Office requirements, Band 2 clinical and non clinical roles and Band 3 non clinical roles are not eligible for sponsorship.

All non clinical roles (Agenda for Change Bands 7 9) that meet the prescribed skill level (RQF 6) and salary threshold will be eligible for sponsorship. The Trust will accept applications from candidates who can evidence their right to work in the UK or via alternative visa routes.

Disability Confident Employer and Guaranteed Interview Scheme

BCHC offers a guaranteed interview to any candidate who is disabled, neurodiverse, has a hidden or long term health condition as recognised under the Equality Act 2010, provided they meet the essential criteria of the job role, as set out in the person specification. We encourage applicants to request any reasonable adjustments where required.

Equality, Diversity and Inclusion

We actively foster and support a workplace culture that is inclusive and equitable for all staff, patients and service users. We encourage applications from individuals of all backgrounds, including those with diverse abilities, experiences and perspectives.

Promoting Workforce Equality

We are committed to the employment and career development of individuals with protected characteristics. The Trust guarantees an interview to any applicants from under represented groups for positions at Band 8a and above whose application meets the essential criteria for the post.

DBS Costs

All new employees starting work with the Trust will be charged for the cost of the DBS check, if required. The cost will be deducted from salary in three payments over three months once employment starts.

Flexible Working

BCHC supports a variety of flexible working practices. Where possible, and dependent on the requirements of the role, we will actively consider requests to enable a mixture of home/base working.

Benefits of working for us:

• Full NHS terms and conditions including extensive holidays and Agenda for Change pay with enhancements
• Attractive relocation payment if you relocate to the local area
• Discounts for local and national retailers
• Dedicated well being services for all employees
• Flexible working where possible

Employer certification / accreditation badges

You must have appropriate UK professional registration.

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and Disclosure and Barring Service submission will be required.

Application numbers

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

Birmingham Community Healthcare NHS Trust
3, Priestley Wharf
Holt Street
Birmingham Science Park
B7 4BN

Office hours: Monday to Friday: 08:30 - 17:00

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