Job summary
A challenging and rewarding opportunity has arisen within the Sterile Services Department which provides decontamination services, including for flexible endoscopes, across the Trust and to a number of other clinical users within Cambridgeshire and the surrounding area.
This key position within the department's management team requires you to operate and manage the quality assurance system for the processing reusable medical devices. You should also have of experience of working in the medical device decontamination of reusable sector.
Main duties of the job
You should ideally be a graduate or have undertaken an equivalent level qualification and possess:
Knowledge of ISO13485 2016 version in relation to the processing of reusable medical devices.
An understanding of HTM 01-01 and HTM 01-06 and their application to the decontamination of reusable medical devices.
Knowledge of the processes relating to the decontamination reusable medical devices used for surgical procedures.
High personal and professional standards and be able to instil these values in others.
Excellent interpersonal, organisational and planning skills.
The ability to thrive on the challenges of working within a large and evolving department that serves an organisation that is at the leading edge of healthcare in the UK.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 11000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 24th July 2023.
Interviews are due to be held on the 2nd August 2023.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 24th July 2023.
Interviews are due to be held on the 2nd August 2023.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- Management qualification at NVQ Level 4 or equivalent.
- Training/assessing qualification A1/A2 or similar.
Desirable
- Full membership of the Institute of Decontamination Sciences.
- V1 Verifiers Qualification
Experience
Essential
- To have an in-depth knowledge of the processes undertaken in a Sterile Services Department or a comparable area, preferably a production type environment that operates a clean room facility.
- Experience of managing a Quality Assurance system.
- Experience of environmental monitoring.
- Experience of working in a junior management role.
Desirable
- Extensive experience of working in a management role in a Sterile Services Department or comparable area.
- Experience of maintaining and developing a Quality System such as ISO9001-2000 or EN13485-2016.
- Involvement in the delivery of training, preferably of vocational qualifications.
Knowledge
Essential
- The requirements of a Quality System, in particular ISO EN13485-2016 and the Medical Devices Directive.
- Knowledge of HTM01-01 and HTM 01-06 as BS EN285:2006 and BS ENISO15883 parts 1 to 3:2006 or HTM's 2010, 2030 and 2031.
- Knowledge of BS EN ISO 14664 parts 1 to 4.
- Knowledge of the training needs of Sterile Services production staff.
- Knowledge of computerised tracking and traceability systems for re-usable medical devices, in particular T-DOC.
Desirable
- Thorough knowledge of quality standards and procedures relating to Sterile Services.
- Knowledge of vocational qualifications.
- Good working knowledge of T-DOC.
- Knowledge of Risk Management in the work place.
Skills
Essential
- A good communicator in both the written and oral format.
- Good interpersonal skills, diplomatic and approachable.
- Ability to negotiate/manage the expectation of service users.
- Ability to communicate complex information to lay people.
- An ability to implement change, particularly in relation to the maintenance and development of a Quality System such as ISO13485-2016.
- Good IT skills, in particular Word, Excel, Powerpoint and database work.
- Ability to extract, manipulate and analyse data effectively .
Desirable
- Proven ability to produce Standard Operational.
- Procedures and working instructions in a format suitable for a certificated Quality System.
Additional Requirements
Essential
- Able to work on own initiative and as part of a team.
- Assertive, motivated, proactive and determined.
- Maintain & enhance own skills and knowledge in line with service needs.
- There will be a requirement to work a limited number of weekends a year.
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of kind, safe and excellent.
Person Specification
Qualifications
Essential
- Management qualification at NVQ Level 4 or equivalent.
- Training/assessing qualification A1/A2 or similar.
Desirable
- Full membership of the Institute of Decontamination Sciences.
- V1 Verifiers Qualification
Experience
Essential
- To have an in-depth knowledge of the processes undertaken in a Sterile Services Department or a comparable area, preferably a production type environment that operates a clean room facility.
- Experience of managing a Quality Assurance system.
- Experience of environmental monitoring.
- Experience of working in a junior management role.
Desirable
- Extensive experience of working in a management role in a Sterile Services Department or comparable area.
- Experience of maintaining and developing a Quality System such as ISO9001-2000 or EN13485-2016.
- Involvement in the delivery of training, preferably of vocational qualifications.
Knowledge
Essential
- The requirements of a Quality System, in particular ISO EN13485-2016 and the Medical Devices Directive.
- Knowledge of HTM01-01 and HTM 01-06 as BS EN285:2006 and BS ENISO15883 parts 1 to 3:2006 or HTM's 2010, 2030 and 2031.
- Knowledge of BS EN ISO 14664 parts 1 to 4.
- Knowledge of the training needs of Sterile Services production staff.
- Knowledge of computerised tracking and traceability systems for re-usable medical devices, in particular T-DOC.
Desirable
- Thorough knowledge of quality standards and procedures relating to Sterile Services.
- Knowledge of vocational qualifications.
- Good working knowledge of T-DOC.
- Knowledge of Risk Management in the work place.
Skills
Essential
- A good communicator in both the written and oral format.
- Good interpersonal skills, diplomatic and approachable.
- Ability to negotiate/manage the expectation of service users.
- Ability to communicate complex information to lay people.
- An ability to implement change, particularly in relation to the maintenance and development of a Quality System such as ISO13485-2016.
- Good IT skills, in particular Word, Excel, Powerpoint and database work.
- Ability to extract, manipulate and analyse data effectively .
Desirable
- Proven ability to produce Standard Operational.
- Procedures and working instructions in a format suitable for a certificated Quality System.
Additional Requirements
Essential
- Able to work on own initiative and as part of a team.
- Assertive, motivated, proactive and determined.
- Maintain & enhance own skills and knowledge in line with service needs.
- There will be a requirement to work a limited number of weekends a year.
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of kind, safe and excellent.
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).
Employer details
Employer name
Cambridge University Hospital NHS Foundation Trust
Address
Addenbrookes Hospital - Corporate
Hills Road
Cambridge
CB2 0QQ
Employer's website
https://www.cuh.nhs.uk (Opens in a new tab)