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For Companies At a Glance
- Tasks: Ensure top-notch quality and compliance for innovative medical software.
- Company: Exciting neurotechnology start-up in London focused on brain monitoring.
- Benefits: Equity plan, private health insurance, unlimited holiday, and mental health support.
- Why this job: Join a mission to save lives with cutting-edge neuromonitoring technology.
- Qualifications: Experience in QA/RA for medical devices and strong regulatory knowledge.
- Other info: Collaborative environment with opportunities for personal and professional growth.
The predicted salary is between 48000 - 72000 £ per year.
New opportunity for a QARA Software Engineer with experience in Medical Devices to join one of London's most exciting neurotechnology start-ups. We are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. By joining us, you will help create cutting-edge technologies to improve diagnosis and treatment of brain disorders, ultimately saving lives worldwide.
The Role
We seek a Senior QA/RA Engineer focused on software quality assurance and regulatory compliance for medical devices. You will ensure our medical software meets the highest quality and regulatory standards.
QARA Software Specialist Location: London (on-site 4 days/week) Salary: Dependent on experience + benefits
Responsibilities
- Develop, implement, and maintain software QA processes compliant with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR.
- Lead software validation and verification activities, including test planning, execution, and documentation.
- Collaborate with software engineers to ensure SDLC compliance, including risk management (ISO 14971) and cybersecurity.
- Support regulatory submissions by preparing documentation such as Software Development Plans, DHF, and SBOM.
- Address and document non-conformances, CAPAs, and audits related to software.
Skills & Experience
- Experience in QA/RA for medical device software or related fields.
- Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations.
- Experience with software validation, V&V testing, and risk management (ISO 14971).
- Familiarity with configuration management, cybersecurity standards, and AI/ML regulations is a plus.
- Hands-on with document control systems (e.g., eQMS), CAPA, and audits.
- Analytical, detail-oriented, with excellent communication skills to translate regulatory requirements into engineering processes.
Additional Benefits
- Company equity plan
- Company pension scheme
- Private medical, dental, and vision insurance
- Group life assurance
- Mental health support
- Unlimited holiday (+ bank holidays)
- Weekly lunches, breakfast, and snacks
Additional Details
- Senior level: Mid-Senior
- Employment type: Full-time
- Job function: Engineering and Quality Assurance
- Industries: Medical Equipment Manufacturing, Biotechnology Research
Senior QA Engineer - Medical Device Software in London employer: CT19
Contact Detail:
CT19 Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Engineer - Medical Device Software in London
✨Tip Number 1
Network like a pro! Reach out to people in the medical device industry, especially those working in QA. Attend meetups or webinars, and don’t be shy about asking for informational interviews. You never know who might have a lead on your dream job!
✨Tip Number 2
Show off your skills! Create a portfolio that highlights your experience with ISO standards and software validation. Use real examples of your work to demonstrate how you’ve tackled challenges in QA. This will make you stand out when chatting with potential employers.
✨Tip Number 3
Prepare for interviews by brushing up on your knowledge of regulations like FDA 21 CFR Part 820 and EU MDR. Be ready to discuss how you’ve implemented these in past roles. Practice common interview questions related to QA processes to boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for talented individuals like you. Keep an eye on our job postings and make sure your application reflects your passion for improving brain monitoring technology.
We think you need these skills to ace Senior QA Engineer - Medical Device Software in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior QA Engineer role. Highlight your experience with medical device software and relevant regulations like ISO 13485 and FDA standards. We want to see how your skills align with our mission!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Share your passion for neurotechnology and how you can contribute to our cutting-edge projects. Let us know why you're excited about improving brain disorder treatments.
Showcase Your Experience: In your application, be specific about your past experiences in QA/RA for medical devices. Mention any hands-on work with software validation and risk management. We love seeing concrete examples of your expertise!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at CT19
✨Know Your Regulations
Make sure you brush up on ISO 13485, IEC 62304, and FDA regulations before the interview. Being able to discuss these standards confidently will show that you’re not just familiar with them, but that you can apply them in real-world scenarios.
✨Showcase Your Experience
Prepare specific examples from your past work where you led software validation or handled regulatory submissions. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your impact.
✨Collaborate Like a Pro
Since collaboration with software engineers is key, think of instances where you worked cross-functionally. Be ready to discuss how you ensured SDLC compliance and managed risks effectively while working with other teams.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to quality assurance and regulatory compliance. This shows your genuine interest in their processes and helps you gauge if their values align with yours.
