Senior QARA Engineer - Software

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Senior QARA Engineer - Software

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CoMind3 months ago Be among the first 25 applicantsJoin to apply for the

Senior QARA Engineer - Software

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CoMindAt 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 (VandV) 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 and Experience:

Demonstrable experience in QA/RA for software in medical devices or a related fieldStrong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for softwareExperience with software validation, VandV testing, and risk management (ISO 14971)Familiarity with software configuration management, cybersecurity standards, and AI/ML regulatory considerations is a plusHands-on experience with document control systems (e.g., eQMS), CAPA management, and audit processesStrong analytical and problem-solving skills with a detail-oriented mindsetExcellent communication skills, with the ability to translate regulatory requirements into practical engineering processes.

Benefits:

Company equity planCompany pension schemePrivate medical, dental and vision insuranceGroup life insuranceComprehensive mental health support and resourcesUnlimited holiday allowance (+ bank holidays)Weekly lunchesBreakfast and snacks provided.

Seniority level

Seniority level Mid-Senior levelEmployment type

Employment type Full-timeJob function

Job function Engineering and Information TechnologyIndustries Medical Equipment ManufacturingReferrals increase your chances of interviewing at CoMind by 2xGet notified about new Senior Software Engineer jobs in

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