Sterile Services Quality Co-ordinator

Job summary
An exciting opportunity has arisen for a driven, well-organised individual with great communication skills and high attention to detail to apply for the role of Quality Co-ordinator in Sterile Services at University Hospitals Coventry & Warwickshire (UHCW) NHS Trust.

The successful applicant will need expertise in these areas :

• Standards and Compliance: familiarity with framework requirements (eg ISO13485:2016, MDR), regulatory audit readiness, and maintaining document hierarchies.
• Corrective and Preventive Action (CAPA): Proficiency in structured root cause analysis (RCA) methods such as 5 Whys, Fishbone diagrams, and tracking action effectiveness.
• Process Control and Metrics: Managing non-conformances (NCRs), change control systems, and monitoring performance via Key Performance Indicators (KPIs).
• Auditing: Planning, executing, and reporting internal and external audits, plus handling follow-up actions.
• Risk Management: Identifying operational, product or process risks, evaluating impact, and putting mitigation controls in place.
• Supplier and Vendor Quality: Qualification criteria, handling supplier deviations, and aligning external partners with internal standards.
• Culture and Leadership: Driving a proactive quality mindset, cross-functional communication, and influencing stakeholders resistant to change.

Successful applicants will be required to provide an immunisation and vaccination report, from either their current UK occupational health provider or their UK GP.

Main duties of the job
To lead a customer-focused Quality Management System within Sterile Services in which Trust and external customers have confidence. To implement effective quality control and risk management processes to ensure that the service functions within a framework of continual improvement and effective risk management. To ensure compliance with Trust, National and European safety and regulatory standards and provide advice to Trust services on decontamination-related quality issues as required.

About us
University Hospitals Coventry and Warwickshire NHS Trust, rated as good by the Care Quality Commission, is one of the largest teaching Trusts in the UK.

We are extremely proud of our employees across our hospital sites, with high quality patient care at the heart of everything we do.

Boasting some of the most modern facilities in Western Europe, the Trust is renowned for being at the forefront of research and innovation as part of its blossoming reputation as a worldwide leader in healthcare.

We are proud to be recognised as a Pathway to Excellence designated organisation - please click the link for further details about this prestigious award. Pathway To Excellence - University Hospitals Coventry & Warwickshire (uhcw.nhs.uk)

By joining our exciting journey, you will form part of a passionate, talented team and will be able to access a wide range of learning and development opportunities. There has never been a better time to join our team.

The Trust is committed to building an organisation that makes full use of the talents, skills, experience, and different perspectives available in our diverse society. We want everyone to feel they are respected, valued, can achieve their potential and receive the most appropriate and relevant care. We will create an environment where the equality and human rights principles of fairness, respect, equality, dignity and autonomy are promoted and are part of the organisation's core values.

Job responsibilities
Responsible for working within strict deadlines to manage:

• all aspects of the departments BS EN ISO 13485:2016 and MDR accredited QMS
• implementation and oversight of internal audit schedules
• robust processes to schedule and oversee the calibration of all monitoring & measuring equipment and the validation of all decontamination equipment
• amendments to all QMS controlled documents including (but not limited to) Standard Operating Procedures/ Work Instructions/ Quality Forms/ Memos
• chairing of the departments annual management review of quality meeting, preparing and issuing agendas, producing and issuing minutes
• assisting with practical training of staff on new / changed / loan instrumentation
• working within tight timescales to oversee post market surveillance process
• departmental KPIs and Quality Objectives monthly reporting to management team
• act as the department's management representative, acting as the lead contact during all external Approved Body audits and all correspondence with the MHRA or other statutory bodies.

For further details of the role please see the attached job description.

Closing Date: Please be advised that this job advert will close as soon as sufficient applications have been received.

Person Specification
Qualifications
Essential

• Qualified for internal auditing & implementation of ISO 13485:2016
• General Risk Assessment training
• Medical Device Risk Management training (ISO 14971:2019)
• COSHH Risk Assessment training
• Training in HTM 01-01 parts A to E

Desirable

• Working towards NVQ or equivalent in Decontamination

Experience
Essential

• Extensive experience with:
• Quality Management systems
• Implementing audit mechanisms.
• Production processes of Medical Devices

Desirable

• Extensive experience in sterile services and endoscopy departments

Knowledge
Essential

• Working knowledge of SSD and endoscopy processes.
• Working knowledge of BS EN ISO 13485:2016

Desirable

• Extensive knowledge of theatre instrumentation

Skills
Essential

• Ability to work on own initiative, unsupervised
• Organizational skills
• Time Management skills
• Good communication skills
• Personable
• Team worker
• PC literate
• Good report writing skills

Commitment to Trust Values and Behaviours
Essential

• Must be able to demonstrate behaviours consistent with the Trust's values. (As detailed in UHCW's Values in Action document below)
• Applicants applying for job roles with managerial responsibility will be required to demonstrate evidence of promoting equal opportunities through work experience

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).

Employer details
Employer name: University Hospitals Coventry and Warwickshire NHS Trust
Address: University Hospitals Coventry and Warwickshire, Clifford Bridge Road, Coventry, CV2 2DX, United Kingdom
Employer's website:

Employer contact details
For questions about the job, contact: SSD Production & Development Manager, Neil Harper, View email address on meeveem.com, View phone number on meeveem.com