At a Glance
- Tasks: Lead software quality assurance processes to ensure safe and impactful digital health services.
- Company: Join Genomics England, a leader in genomic healthcare innovation.
- Benefits: Enjoy 30 days holiday, flexible working, and generous pension contributions.
- Other info: Be part of a diverse team committed to inclusivity and professional growth.
- Why this job: Make a real difference in healthcare by ensuring quality and compliance in software delivery.
- Qualifications: Experience in software quality assurance within regulated environments, ideally in healthcare.
The predicted salary is between 75000 - 75000 £ per year.
Full-time Department: Quality, Improvement and Regulations Office: London
Daily Responsibilities
- Lead and evolve software quality assurance processes across Genomics England to ensure safe, reliable, and impactful digital and genomic services.
- Shape and maintain quality frameworks that enable secure, ethical, and compliant software delivery in a data-driven healthcare environment.
- Support the development and maturity of the Software Development Lifecycle (SDLC), aligned with UK Medical Device Regulations and organisational priorities.
- Ensure quality, safety, and regulatory requirements are embedded from early design through to delivery and ongoing operation.
- Drive compliance with key standards, including IEC 62304, across Software as a Medical Device (SaMD) and digital health solutions.
- Provide expert guidance on risk management activities, ensuring patient safety, data integrity, and regulatory compliance are consistently maintained.
- Partner closely with engineering, software QA, and QIRA teams to embed clear and practical quality requirements across delivery.
- Strengthen requirements management, traceability, and verification & validation (V&V) practices across the software lifecycle.
- Review and improve quality documentation, procedures, and configuration management to ensure transparency, auditability, and compliance.
- Champion a culture of quality by design, supporting teams to deliver innovative solutions while maintaining high standards of safety, trust, and regulatory assurance.
Skills & Experience
- Experience in software development or software quality assurance within a regulated environment, ideally in healthcare, digital health, or Software as a Medical Device (SaMD), with understanding of UK MDR / EU MDR expectations.
- Solid knowledge of regulated software development standards and frameworks, including IEC 62304, with awareness of ISO 13485 and ISO 14971.
- Experience contributing to the design, improvement, or governance of the Software Development Lifecycle (SDLC), including embedding quality and compliance within Agile or DevOps environments.
- Experience supporting risk management activities and working within or alongside a Quality Management System (QMS), including risk assessment, documentation control, audit readiness, and regulatory inspection support.
- Effective collaborator, working with engineers, software QA, and quality and regulatory teams to align technical delivery with patient safety and compliance.
- Confident communicator and stakeholder engager, with the ability to influence positively and translate regulatory expectations into practical, actionable guidance for teams.
Note: This is not a software testing role. It is a quality assurance and compliance role requiring significant understanding of software engineering and delivery practices.
MSc/BSc Degree in Engineering, Quality, Architecture, Design or equivalent.
Salary from: £75,000
Benefits
- Generous Leave: 30 days’ holiday plus bank holidays, additional leave for long service, and the option to apply for up to 30 days of remote working abroad annually (approval required).
- Family-Friendly: Blended working arrangements, flexible working, enhanced maternity, paternity and shared parental leave benefits.
- Pension & Financial: Defined contribution pension (Genomics England double-matches up to 10%, however you can contribute more if you wish), Life Assurance (3x salary), and a Give As You Earn scheme.
- Learning & Development: Individual learning budgets, support for training and certifications, and reimbursement for one annual professional subscription (approval required).
- Recognition & Rewards: Employee recognition programme and referral scheme.
- Health & Wellbeing: Subsidised gym membership, a free Headspace account, and access to an Employee Assistance Programme, eye tests, flu jabs.
Equal Opportunities
Genomics England is actively committed to providing and supporting an inclusive environment that promotes equity, diversity and inclusion best practice within our community and in any other area where we have influence. We are proud of our diverse community where everyone can come to work and feel welcomed and treated with respect regardless of any disability, ethnicity, gender, gender identity, religion, sexual orientation, or social background. Genomics England’s policies of non‑discrimination and equity will be applied fairly to all people, regardless of age, disability, gender identity or reassignment, marital or civil partnership status, being pregnant or recently becoming a parent, race, religion or beliefs, sex or sexual orientation, length of service, whether full or part‑time or employed under a permanent or a fixed‑term contract or any other relevant factor. Genomics England does not tolerate any form of discrimination, harassment, victimisation or bullying at work. Such behaviour undermines our mission and core values and diminishes the dignity, respect and integrity of all parties. Our People policies outline our commitment to inclusivity. We aim to remove barriers in our recruitment processes and be flexible with our interview processes. Should you require any adjustments that may help you fully participate in the recruitment process, we encourage you to discuss these with us.
Lead, SaMD Design Assurance employer: Genomics England Limited
Genomics England is an exceptional employer, offering a dynamic work environment in London that prioritises quality and innovation in healthcare technology. With generous leave policies, flexible working arrangements, and a strong commitment to employee development, we foster a culture of inclusivity and support for personal and professional growth. Join us to be part of a mission-driven team dedicated to delivering impactful digital and genomic services while ensuring the highest standards of safety and compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Lead, SaMD Design Assurance
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those at Genomics England. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s values and recent projects. Show us how your experience aligns with their mission, especially around quality assurance and compliance in healthcare.
✨Tip Number 3
Don’t just talk about your skills; demonstrate them! Bring examples of how you've tackled challenges in software quality assurance, particularly in regulated environments. We love seeing real-world applications!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows us you’re genuinely interested in being part of our team at Genomics England.
We think you need these skills to ace Lead, SaMD Design Assurance
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in software quality assurance, especially in regulated environments like healthcare. We want to see how your skills align with our needs!
Showcase Your Knowledge:Don’t forget to mention your understanding of key standards like IEC 62304 and UK MDR. We’re looking for someone who can hit the ground running, so let us know how you’ve applied this knowledge in past roles.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, so make sure your achievements and experiences are easy to read and understand.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Genomics England Limited
✨Know Your Standards
Familiarise yourself with key standards like IEC 62304 and ISO 13485. Be ready to discuss how these frameworks apply to your experience in software quality assurance, especially in a healthcare context.
✨Showcase Your Collaboration Skills
Prepare examples of how you've worked closely with engineering and QA teams. Highlight your ability to translate regulatory expectations into actionable guidance, as this role requires effective collaboration across various teams.
✨Demonstrate Risk Management Expertise
Be prepared to talk about your experience with risk management activities. Discuss specific instances where you ensured patient safety and compliance, showcasing your understanding of the importance of these elements in software delivery.
✨Emphasise Quality by Design
Illustrate your commitment to a culture of quality by design. Share examples of how you've championed high standards in previous roles, and be ready to discuss how you would support teams in delivering innovative solutions while maintaining compliance.
