Senior QARA Engineer - Software

Crane Venture Partners; City Of London; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A medical technology firm is seeking a QA/RA Engineer to ensure software quality assurance and regulatory compliance for medical devices. The role involves developing QA processes, leading validation activities, and supporting regulatory submissions. Candidates should have experience with ISO 13485, software validation, and excellent communication skills. This position offers flexible hybrid work arrangements and a comprehensive benefits package, including company equity and health insurance.

Benefits

Company equity plan

Private medical insurance

Unlimited holiday allowance

Qualifications

• Proven experience in QA/RA for software in medical devices.
• Expertise in ISO 13485, IEC 62304 regulations.
• Strong V&V testing experience.

Responsibilities

• Develop and maintain QA processes per regulatory standards.
• Lead software validation and verification activities.
• Support regulatory submissions with necessary documentation.

Skills

Experience in QA/RA for medical device software

Knowledge of ISO 13485 and IEC 62304

Experience with software validation

Strong analytical and problem-solving skills

Excellent communication skills

Job description

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.