Job summary
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.
About us
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.
Job description
Job 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.
Job description
Job 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.
Person Specification
Qualifications
Essential
- Recognised qualification in a relevant healthcare science such as IDSC Technical Certificate and be able to demonstrate equivalent experience in similar quality driven industrial or commercial environment and working at a supervisory level within that industry. Demonstrate exceptional knowledge backed up with detailed experience in a production or similar regulated industry environment
- Further appropriate qualifications relevant to role which may include LEAN / KAIZEN continual process improvement or other good working practices leading to efficiency and effective management or provide evidence of previous experience.
- Has completed BSI or equivalent ISO Internal auditors' course or relevant measurable experience in carrying out internal quality audits.
- Membership of the Institute of Decontamination Sciences (IDSc) and or Central Sterilizing Club (CSC) or equivalent national body.
- Significant supervisory experience in a lead role working autonomously to meet the requirements of a regulated activity. Experience in being involved with both internal and external audits such as BSI, CQC or JAG and provide evidence of leading and implementing change,
- Excellent technical and communications skills and the ability to inspire motivate and lead staff. Dealing with complex or sensitive issues an effective and positive manner
- Ability to provide precise detailed explanations on quality system related matters, understand and evaluate technical. reports and other regulatory requirements
- Ability to review technical data from decontamination and other tracking database systems involving complex data review and management of that data to demonstrate adherence to KPI's.
- Extensive understanding and experience in the management of medical devices to MHRA requirements, Field Safety notes and product recalls.
Desirable
- Ability to understand and explain the differences and expectations between EQR and BP (as per the requirements of HTM01- 01 for policy and procedure development and develop action plans accordingly
- Have a detailed and significant experience of instrument Tracking & Traceability systems and their use. Have a good working summary knowledge of the relevant documents pertaining to Surgical Instrument Decontamination Be able to state and demonstrate the requirements for the handling and reprocessing of "high Risk" surgical instrumentation and principles around nonconformance and quarantining controlled storage of products to prevent in inadvertent use.
- Creation and ongoing management of visual QMS compliance dashboards for the Management of maintenance, testing Validation and Staff training requirements
- Experience in identifying and contributing to annual business planning processes
- Responsive to change and positively review and adapt to innovative technology or methods of working, in response to Changes in the service or regulatory requirements.
Person Specification
Qualifications
Essential
- Recognised qualification in a relevant healthcare science such as IDSC Technical Certificate and be able to demonstrate equivalent experience in similar quality driven industrial or commercial environment and working at a supervisory level within that industry. Demonstrate exceptional knowledge backed up with detailed experience in a production or similar regulated industry environment
- Further appropriate qualifications relevant to role which may include LEAN / KAIZEN continual process improvement or other good working practices leading to efficiency and effective management or provide evidence of previous experience.
- Has completed BSI or equivalent ISO Internal auditors' course or relevant measurable experience in carrying out internal quality audits.
- Membership of the Institute of Decontamination Sciences (IDSc) and or Central Sterilizing Club (CSC) or equivalent national body.
- Significant supervisory experience in a lead role working autonomously to meet the requirements of a regulated activity. Experience in being involved with both internal and external audits such as BSI, CQC or JAG and provide evidence of leading and implementing change,
- Excellent technical and communications skills and the ability to inspire motivate and lead staff. Dealing with complex or sensitive issues an effective and positive manner
- Ability to provide precise detailed explanations on quality system related matters, understand and evaluate technical. reports and other regulatory requirements
- Ability to review technical data from decontamination and other tracking database systems involving complex data review and management of that data to demonstrate adherence to KPI's.
- Extensive understanding and experience in the management of medical devices to MHRA requirements, Field Safety notes and product recalls.
Desirable
- Ability to understand and explain the differences and expectations between EQR and BP (as per the requirements of HTM01- 01 for policy and procedure development and develop action plans accordingly
- Have a detailed and significant experience of instrument Tracking & Traceability systems and their use. Have a good working summary knowledge of the relevant documents pertaining to Surgical Instrument Decontamination Be able to state and demonstrate the requirements for the handling and reprocessing of "high Risk" surgical instrumentation and principles around nonconformance and quarantining controlled storage of products to prevent in inadvertent use.
- Creation and ongoing management of visual QMS compliance dashboards for the Management of maintenance, testing Validation and Staff training requirements
- Experience in identifying and contributing to annual business planning processes
- Responsive to change and positively review and adapt to innovative technology or methods of working, in response to Changes in the service or regulatory requirements.
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.
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).
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.
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).
