Software QA Engineer

We are working with an exciting BioTech business who are developing technology to enhance the preservation of biological substances. Their solutions improve the quality and viability of stored materials for use in various applications, including medical and agricultural fields.

As a part of their growth, we are seeking an experienced Software Quality Assurance Engineer specialising in regulated medical device software to join their team. This pivotal role is responsible for fostering a quality-driven culture across the organisation, ensuring compliant, high-performing software solutions within a robust Quality Management System (QMS).

About the role

As a Software Quality Assurance Engineer, you will apply specialist knowledge and regulatory expertise to ensure software development activities comply with industry standards and regulations. You will define and implement quality-focused approaches across the entire software development lifecycle (SDLC), from planning and design to verification, validation, and risk management. This role involves collaborating with cross-functional teams, participating in key design reviews, and supporting internal and external audits.

The team will rely on you to:

• Champion quality assurance throughout the software development lifecycle (SDLC), ensuring all activities align with US FDA Quality System Regulations (21 CFR Part 820/11), ISO 13485, IEC 62304, and HIPAA.
• Collaborate cross-functionally with development, engineering, and quality teams to ensure software requirements, design, verification, and validation are compliant.
• Define and implement quality-focused approaches across various SDLC methodologies (Agile, Waterfall, SAFe, DevOps).
• Participate in and approve key design input and output deliverables, such as requirements, test plans, and validation reports.
• Lead and support risk management activities, including system-level risk analysis and software FMEAs.
• Contribute to the creation and maintenance of design and development files, ensuring accuracy and completeness.
• Support internal and external audits, including FDA inspections, as the software development subject matter expert.

Ideally you have:

• 3-5+ years of experience in software quality engineering or quality assurance within the FDA-regulated medical device industry.
• Hands-on involvement in SaMD (Software as a Medical Device) or SiMD (Software in a Medical Device) projects.
• In-depth knowledge of relevant standards and regulations, including 21 CFR Part 820/11, ISO 13485, IEC 62304, ISO 14971, and HIPAA.
• Demonstrated experience with both Agile and Waterfall SDLC methodologies.
• Strong proficiency in risk management, requirements management, verification and validation, and documentation.
• Experience supporting audits, CAPA, complaints, and QMS activities related to software products.
• A Bachelor's or higher degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

Bonus points if you also have:

• Familiarity with AI/ML-based medical device software quality management.
• Advanced working knowledge of cybersecurity risk management and data privacy requirements.
• Experience in collaborating with technical and clinical colleagues.

What's next

If you are a Software Quality Assurance Engineer looking for a rare opportunity to have a big impact on a scaling company, we encourage you to apply. We will be reviewing applications over the coming weeks, and contacting shortlisted candidates for a phone screen before interviewing with the client.