Liverpool University Hospitals NHS Foundation Trust Sterile Services Department. are recruiting an experienced, dynamic and self-motivated Quality Manager to implement and manage the Quality management system ISO13485 for the decontamination and reprocessing of Surgical Instruments from its Central Sterile Services department located at the Broadgreen Hospital site.
Working under the management of the Sterile Services Manager and in conjunction with the Surgical Instrument Manager, you will be involved in all aspects of managing and maintaining our ISO13485 accreditation to our customers at Broadgreen Hospital, Royal Liverpool and Aintree Hospital sites along with the University Dental Hospital.
You must have previous knowledge and experience in surgical instrument reprocessing at a supervisory role or above in a Sterile services Department or similar medical devices manufacturing environment operating to ISO13485 including undertaking internal quality audits and experience with external notified body visits. Your number one priority is ensuring that the quality system of the department is rigorously maintained.
- To monitor and review, implement and procedures and other work instructions, for the receipt, sort, disassemble, decontamination, packing, sterilisation, storage and despatch of surgical instruments in compliance with ISO 13485 and the Medical Devices Regulations (MDR) 2017-745
- Communicate and implement revisions in working procedures with SSD staff and monitor staff production against the implemented QMS procedures and through an established internal quality audit programme.
- Attend external notified body audits in conjunction with the SSD manger. Provide notified body auditors with QMS driven documentation and validation reports on request. There is also a requirement to attend unannounced notified body visits as they occur.
Liverpool University Hospitals NHS Foundation Trust comprises Aintree University Hospital, Broadgreen Hospital & Royal Liverpool University Hospital.
We are part of NHS University Hospitals of Liverpool Group, formed on 1 Nov 2024 from the coming together of LUHFT and Liverpool Women’s NHS Foundation Trust. The Group was born from a shared aim to improve the care we provide our patients.
UHLG is one of the largest employers in the region, with over 16,800 colleagues dedicated to caring for our communities - from birth and beyond.
For the 630,000 people across Merseyside, we are their local NHS. We provide general and emergency hospital care, alongside highly specialised regional services for more than two million people in the North West.
Aintree University Hospital is the single receiving site for adult major trauma patients in Cheshire and Merseyside and hosts a number of regional services including an award-winning stroke facility. Broadgreen Hospital is home to elective surgical, diagnostic and treatment services, together with specialist patient rehabilitation. Liverpool Women’s Hospital specialises in the health of women and babies, delivering over 7,200 babies in the UK’s largest single site maternity hospital each year. The Royal Liverpool University Hospital is the largest hospital in the country to provide inpatients with 100% single bedrooms and focuses on complex planned care and specialist services.
For roles at Liverpool Women’s, visit their careers page .
- To monitor and review, implement and procedures and other work instructions, for the receipt, sort, disassemble, decontamination, packing, sterilisation, storage and despatch of surgical instruments in compliance with ISO 13485 and the Medical Devices Regulations (MDR) 2017-745
- Communicate and implement revisions in working procedures with SSD staff and monitor staff production against the implemented QMS procedures and through an established internal quality audit programme.
- Monitor cleaning schedules and the cleanroom environment. Equipment validation and testing schedules to ensure ongoing compliance.
- In conjunction with the SSD manager, undertake quarterly customer satisfaction survey for all customers and provide feedback and data analysis to rectify any issues and to ensue all customer expectations and agreed KPI are met.
- Following internal audits, and any change in the procedures, meet with all SSD staff to go though and manage changes and training required. Conduct ad-hoc “toolbox” talks providing leadership and feedback following in incident led changes.
- Attend QMS related, Decontamination, Customer, SSD Staff and Team Leader meetings providing feedback and support following activities or audits and support a culture of change within SSD and SSD users.
- Attend external notified body audits in conjunction with the SSD manger. Provide notified body auditors with QMS driven documentation and validation reports on request. There is also a requirement to attend unannounced notified body visits as they occur.
- Previously knowledge and daily use of IT based Instrument Tracking and Traceability operating systems would be a significant advantage. The Department operates the Healthedge system across all sites.
- Demonstrate a comprehensive understanding of Health Technical Memorandum HTM 01-01 and other relevant standards pertaining to Sterile Service Departments
- Effective communication, responding to telephone calls or emails from service users on a range of different instrument and production queries, and providing investigation and feedback following complaints requiring further monitoring and feedback.
- Attend Quarterly Trust Decontamination Assurance Group meetings.
- Adhere to all Trust and departmental quality standards.
- Act professionally and with dignity and as an inspirational role model to staff at all times.
- Due to working across multiple sites, a driving licence and access to a vehicle would be an advantage. However, hospital inter site transport services are available free to all staff.
- To work flexibility over 37.5 hours per week and at different hours as required to undertake audits and attend meetings across all shift patterns.
- Take responsibility for your own learning needs and professional conduct. Take on board training deemed necessary to attain/maintain competency including trust mandatory training.
