Job summary
Clinical Engineering at Royal Brompton and Harefield hospitals supports the medical equipment of the two sites as well as supporting the hospitals' programmes of care and research through the design and construction of specialist devices.
You will be working at both sites and there may be occasional requirement to visit other Guy's and St Thomas' sites.
We are seeking a highly motivated quality manager to improve and maintain our existing ISO Quality Systems (QS):
* Harmonising processes to improve efficiency, device safety and patient outcomes.
* Ensuring that the QS support the availability, reliability and suitability of the medical equipment.
* Advising on the medical device regulations applied to novel medical devices and maintaining project documentation.
As Medical Devices Safety Officer (MDSO), create a programme of medical device safety improvement:
* Improving the frequency and quality of incident reports involving medical devices.
* Ensuring effective response to manufacturer and MHRA medical device safety notices, alerts from Central Alerting System (CAS), etc.
* Investigating serious device related incidents using a systems approach.
Main duties of the job
Lead the development and operation of the Clinical Engineering ISO13485 and ISO9001 quality systems, focusing on cross-site harmonisation of processes to improve efficiency, device safety and patient outcomes, ensuring the quality systems support the medical equipment fleet availability, reliability and suitability.
In conjunction with the Head of Clinical Engineering, lead medical device governance for the Royal Brompton and Harefield Hospitals, creating a programme of medical device safety improvement including:
* Improving the frequency and quality of incident reports involving devices.
* Responding to nationally reported device safety initiatives.
* Creating and maintaining an effective medical device inventory.
* Managing the departmental Quality Management software (QPulse) and Medical Equipment Management software and database (AIMS).
Act as the local medical devices safety officer (MDSO), ensuring the Trust responds effectively to manufacturer and MHRA device safety notices.
Lead on the investigation of serious device related incidents or significant near misses using a systems approach, implementing the necessary changes in procedure, training, or culture to reduce the likelihood of reoccurrence.
As a member of the devices design team, advise on the requirements of the medical device regulations for novel medical devices to ensure a compliant risk reducing production process allowing devices to be CE/UKCA marked under the ISO 13485 system.
About us
Royal Brompton & Harefield Hospitals, as part of Guy's and St Thomas', is the largest heart and lung centre in the UK and among the largest in Europe. We are a partnership of two specialist hospitals known throughout the world for their expertise, standard of care, and research success.
Person Specification
Knowledge/Qualifications
Essential
* BSc/BEng, or equivalent degree, in a relevant scientific or engineering subject or equivalent. Eligible for membership of a professional institution. Post graduate degree (MSc or equivalent) or relevant post graduate clinical or scientific experience.
Desirable
* Chartered engineer or scientist. Professional registration with either the HCPC as a Clinical Scientist or with the IPEM Register of Clinical Technologists.
Skills
Essential
* Ability to analyse facts in a logical fashion. Ability to discern factual information from sources that might include conjecture, speculation and opinion. Ability to quickly understand a complex clinical environment or procedure to assist incident investigation. Ability to remain calm in potentially stressful situations.
Experience
Essential
* Experience of working with and/or knowledge of, a wide range of medical devices in a hospital environment from simple single-use devices to advanced medical equipment. Good understanding of the scientific and engineering principles applicable to devices and healthcare, underpinned by theoretical knowledge and relevant practical experience. Highly developed specialist knowledge across a range of specialised medical equipment and awareness of relevant national guidelines. Knowledge of the clinical environment and clinical procedures. Experience of operating ISO 9001 and/or 13485 quality systems or other relevant medical device related systems. Experience of audit. Experience in handling device related incidents including, reporting and investigating.
Desirable
* Experience of hosting certification visits.
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.
Certificate of Sponsorship
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 .
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. #J-18808-Ljbffr