Quality Assurance Manager
We are on a mission to help radiologists detect breast cancer earlier using deep learning.
Kheiron is a fast-growing, medical technology company that uses advanced machine learning to develop and deliver intelligent tools for radiologists, radiology departments, imaging centres and hospitals to improve the efficiency, consistency and accuracy of radiology reporting. We aim to save more lives by empowering radiologists in their role in diagnosis, treatment, and patient outcome.
Kheiron has offices in London, San Francisco, Budapest and the Netherlands. We are backed by Connect Ventures, Hoxton Ventures, Atomico, Greycroft and Exor Seeds.
We are proud that Kheiron is one of the winners of the first UK Government Artificial Intelligence (AI) in Health and Care Awards.
The funding will accelerate the roll out and rapid adoption of Mia (Mammography Intelligent Assessment) to address critical challenges in breast screening services.
We are looking for a talented Quality Systems Manager to join our growing QARA Department at Kheiron. This is a really exciting role, reporting directly into our VP of RA/QA. This role will support our international expansion plans as we take our award winning AI products into new markets.
You will work with the cross functional team to maintain support and continuously improve an ISO 13485 certified QMS for SaMD products being sold in the UK, Europe, US and ROW.
We have offices in the UK, US, Hungary and The Netherlands, and are open to candidate’s locations.
What you'll be doing:
- Responsible for maintaining, monitoring and continuously improving the QMS
- Ensure compliance with applicable regulations including EN 62304, 21 CFR 820 , MDSAP and ISO 13485
- Manage internal audit program and report on findings
- Revise, write and author policies and procedures as required to maintain compliance to requirements
- Manage the QMS including change control, supplier qualifications, training, documentation management, quality agreements, CAPA, investigations, risk management, customer complaints, management review etc.
- Lead and manage strategic QA tasks working with clinical and development teams
- Train on QMS processes Educate and train team members regarding their impact on quality
- Perform root cause analysis to identify process improvements or resolve identified problems
- Establish and implement metrics to support process improvements and predict trends
- Oversee validation program
- Support interactions with regulatory agencies
- Interact with other team members to share best practices, lessons learned and implementation of improvements
We'd love you to join if you have:
- Extensive experience working as a Quality professional in the software as a medical device industry; a huge plus if it’s in radiology and/or AI
- Hands-on experience in maintaining a QMS compliant to ISO 13485 for class II devices in Europe and US
- Superb knowledge of ISO 13485, 21 CFR 820, EN 62304, EN 82304, ISO 14791
- Excellent organisation skills, attention to detail and ability to work on several simultaneous projects with tight timelines
- Effective problem solving and communication skills
- ASQ, CQM, CQE certification a plus
What we offer:
- 🏥 Save Lives - be part of a team that changes the way patients are cared for
- 👨🎓👩🎓 Learner-centric Environment - We work in a fast-paced, high impact environment in which you can learn and grow your skill set
- 📈 Equity - We want you to be part of the Kheiron story and all employees will receive equity
- 🌴 Time Off: 22 days + the days between Christmas & New Year + 10 bank holiday days
- 🖥 Technology - Latest IT equipment as well as any accessories you may need
- ❤️ Health - We offer premium health coverage for you, your partner, and your children through Bupa
- 😌 Mental Health - We support mental health through Spill
- 👨👩👧👧 Enhanced Parental Leave - Extended maternity and paternity leave
At Kheiron we celebrate diversity and inclusion, we strive for a work environment in which all individuals are treated fairly and respectfully, have equal access to opportunities and resources, and can contribute fully to the organisation's success.
We are an equal opportunities employer and welcome everyone regardless of race, religion, gender, sexual orientation, age, disability, or marital status.