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For Companies At a Glance
- Tasks: Ensure software quality and compliance for innovative medical devices.
- Company: Join a cutting-edge neurotechnology start-up in London.
- Benefits: Enjoy equity, pension, private insurance, unlimited holiday, and weekly lunches.
- Why this job: Make a real impact on brain health while working with advanced technology.
- Qualifications: Experience in QA/RA for medical device software and strong regulatory knowledge required.
- Other info: On-site role 4 days a week, fostering collaboration and innovation.
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. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world.
The Role
We are seeking a Senior QA/RA Engineer with a strong focus on software quality assurance and regulatory compliance for medical devices. You will play a crucial role in ensuring the software in our medical technology meets the highest quality and regulatory standards.
Responsibilities
- Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR.
- Lead software validation and verification (V&V) activities, including test planning, execution, and documentation.
- Collaborate with software engineers to ensure software development lifecycle (SDLC) compliance, including risk management (ISO 14971) and cybersecurity considerations.
- Support regulatory submissions (e.g., FDA 510(k), CE marking) by preparing software-related documentation such as Software Development Plans, Software Design History Files (DHF), and Software Bill of Materials (SBOM).
- Ensure that non-conformances, CAPAs, and audits related to software are effectively addressed and documented.
Skills & Experience
- Demonstrable experience in QA/RA for software in medical devices or a related field.
- Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software.
- Experience with software validation, V&V testing, and risk management (ISO 14971).
- Familiarity with software configuration management, cybersecurity standards, and AI/ML regulatory considerations is a plus.
- Hands-on experience with document control systems (e.g., eQMS), CAPA management, and audit processes.
- Strong analytical and problem-solving skills with a detail-oriented mindset.
- Excellent communication skills, with the ability to translate regulatory requirements into practical engineering processes.
Benefits:
- Company equity plan.
- Company pension scheme.
- Private medical, dental and vision insurance.
- Group life assurance.
- Comprehensive mental health support and resources.
- Unlimited holiday allowance (+ bank holidays).
- Weekly lunches.
- Breakfast and snacks provided.
Senior QA Engineer - Medical Device Software employer: CT19
Contact Detail:
CT19 Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Engineer - Medical Device Software
✨Tip Number 1
Familiarise yourself with the specific regulations mentioned in the job description, such as ISO 13485 and IEC 62304. Being able to discuss these standards confidently during your interview will demonstrate your expertise and commitment to quality assurance in medical devices.
✨Tip Number 2
Network with professionals in the neurotechnology and medical device sectors. Attend relevant industry events or webinars to connect with potential colleagues and learn more about the latest trends and challenges in QA for medical software.
✨Tip Number 3
Prepare to discuss your hands-on experience with document control systems and CAPA management. Be ready to provide examples of how you've effectively addressed non-conformances and contributed to successful audits in your previous roles.
✨Tip Number 4
Showcase your problem-solving skills by preparing case studies or scenarios where you successfully navigated regulatory challenges. This will highlight your analytical abilities and your capacity to translate complex regulatory requirements into practical solutions.
We think you need these skills to ace Senior QA Engineer - Medical Device Software
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in QA/RA for medical devices, particularly focusing on software quality assurance. Include specific examples of your work with ISO 13485, IEC 62304, and FDA regulations.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your passion for neurotechnology and how you can contribute to improving patient outcomes. Mention any relevant projects or experiences that align with the company's mission.
Highlight Relevant Skills: In your application, emphasise your analytical and problem-solving skills, as well as your familiarity with software validation and risk management. Be specific about your hands-on experience with document control systems and CAPA management.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a role in QA/RA.
How to prepare for a job interview at CT19
✨Know Your Regulations
Familiarise yourself with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations. Be prepared to discuss how your experience aligns with these standards and how you can ensure compliance in the role.
✨Demonstrate V&V Expertise
Be ready to share specific examples of your experience with software validation and verification activities. Highlight your approach to test planning, execution, and documentation, as this will be crucial for the role.
✨Showcase Problem-Solving Skills
Prepare to discuss past challenges you've faced in QA/RA and how you resolved them. Emphasising your analytical skills and attention to detail will show that you're equipped to handle the complexities of medical device software.
✨Communicate Effectively
Practice explaining regulatory requirements in a way that is understandable to engineers. Strong communication skills are essential, so be ready to demonstrate how you can bridge the gap between regulatory compliance and engineering processes.
