Quality Manager

Job overview

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.

Main duties of the job

• 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.

Detailed job description and main responsibilities

• 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.