Senior QARA Engineer - Software

Crane Venture Partners; London; Hybrid; GBP 45,000 - 70,000; Full time

Job summary

A leading company is seeking a QA/RA Engineer to ensure software quality and regulatory compliance for innovative medical devices. Responsibilities include implementing QA processes, overseeing software validation efforts, and preparing regulatory documentation. This role offers competitive compensation, hybrid working, and a range of benefits to support employee well-being.

Benefits

Company equity plan

Company pension scheme

Private medical, dental and vision insurance

Group life assurance

Comprehensive mental health support

Unlimited holiday allowance (+ bank holidays)

Quarterly work-from-anywhere policy

Weekly lunches

Breakfast and snacks provided

Qualifications

• Experience in QA/RA for software in medical devices or related field.
• Strong knowledge of relevant regulations and compliance standards.
• Experience with software validation, V&V testing, and risk management.

Responsibilities

• Maintain QA processes in compliance with medical device regulations.
• Lead software validation activities and document appropriately.
• Support regulatory submissions with necessary documentation.

Skills

QA/RA experience for medical devices

Knowledge of ISO 13485

Experience with V&V testing

Risk management (ISO 14971)

Analytical skills

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.