Join to apply for the Senior QARA Engineer - Software role at CoMind

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Join to apply for the Senior QARA Engineer - Software role at CoMind

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.
  
  

• 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.
  
  

• Company equity plan
• Company pension scheme
• Private medical, dental and vision insurance
• Group life insurance
• Comprehensive mental health support and resources
• Unlimited holiday allowance (+ bank holidays)
• Weekly lunches
• Breakfast and snacks provided.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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