Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Ensure software quality and regulatory compliance for innovative medical technology.
- Company: Join CoMind, a pioneer in non-invasive neuromonitoring technology transforming brain disorder treatment.
- Benefits: Enjoy unlimited holiday, hybrid working, company equity, and comprehensive health support.
- Why this job: Be part of a mission to improve lives through cutting-edge technology in a supportive culture.
- Qualifications: Experience in QA/RA for medical device software and knowledge of relevant regulations required.
- Other info: Collaborate with engineers and lead validation activities in a dynamic, impactful environment.
The predicted salary is between 43200 - 72000 £ per year.
At CoMind, 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 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)
-
Hybrid working (minimum 3 days in-office)
-
Quarterly work-from-anywhere policy
-
Weekly lunches
-
Breakfast and snacks provided.
#J-18808-Ljbffr
Senior QARA Engineer - Software employer: Crane Venture Partners
Contact Detail:
Crane Venture Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QARA Engineer - Software
✨Tip Number 1
Familiarise yourself with the specific regulations mentioned in the job description, such as ISO 13485 and IEC 62304. Understanding these standards will not only help you during interviews but also demonstrate your commitment to quality assurance in medical devices.
✨Tip Number 2
Network with professionals in the QA/RA field, especially those who work with medical software. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in software quality assurance.
✨Tip Number 3
Prepare to discuss your hands-on experience with document control systems and CAPA management. Be ready to share specific examples of how you've successfully navigated audits or addressed non-conformances in previous roles.
✨Tip Number 4
Showcase your analytical and problem-solving skills by preparing case studies or scenarios where you effectively resolved quality issues. This will highlight your ability to translate regulatory requirements into practical solutions, which is crucial for this role.
We think you need these skills to ace Senior QARA Engineer - Software
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in QA/RA for software in medical devices. Emphasise your knowledge of relevant regulations like ISO 13485 and FDA 21 CFR Part 820, as well as any hands-on experience with document control systems.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving patient outcomes through technology. Mention specific projects or experiences that demonstrate your skills in software validation and regulatory compliance.
Showcase Relevant Skills: Clearly outline your analytical and problem-solving skills in your application. Provide examples of how you've successfully managed non-conformances or CAPAs in previous roles to show your attention to detail.
Prepare for Technical Questions: Anticipate technical questions related to software quality assurance processes and regulatory standards during the interview. Be ready to discuss your experience with risk management and cybersecurity considerations in medical device software.
How to prepare for a job interview at Crane Venture Partners
✨Know Your Regulations
Familiarise yourself with ISO 13485, IEC 62304, and FDA regulations. Be prepared to discuss how your experience aligns with these standards and how you can ensure compliance in the role.
✨Showcase Your V&V Experience
Highlight your experience in software validation and verification activities. Be ready to provide examples of test planning, execution, and documentation you've handled in previous roles.
✨Demonstrate Collaboration Skills
Emphasise your ability to work with software engineers and other teams. Discuss how you’ve collaborated on ensuring SDLC compliance and managing risks effectively.
✨Prepare for Regulatory Submission Questions
Anticipate questions about your experience with regulatory submissions like FDA 510(k) or CE marking. Be ready to explain how you prepare software-related documentation and address non-conformances.
