At a Glance
- Tasks: Lead software quality assurance 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 equity.
- Why this job: Shape the future of healthcare with cutting-edge technology and make a real difference.
- Qualifications: Experience in software QA or development in regulated environments, ideally healthcare.
The predicted salary is between 55000 - 65000 € per year.
We are seeking a Design Assurance Lead to drive excellence in software quality assurance at Genomics England, shaping organisational practice and supporting the delivery of an enhanced software development lifecycle aligned with future UK Medical Device Regulations.
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.
Qualifications
- 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.
- MSc/BSc Degree in Engineering, Quality, Architecture, Design or equivalent.
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 (3× 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 fully committed to providing and supporting an inclusive environment that promotes equity, diversity and inclusion best practice both within our community and in any other areas 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 to be flexible with our interview processes. Should you require any adjustments that may help you to fully participate in the recruitment process, we encourage you to discuss this with us.
Design Assurance Lead employer: Genomics England
Genomics England is an exceptional employer, offering a dynamic work environment that prioritises quality and innovation in healthcare technology. With generous leave policies, flexible working arrangements, and a strong commitment to employee development, we empower our team members to thrive both personally and professionally. Our inclusive culture fosters collaboration and respect, ensuring that every voice is heard as we work together to deliver impactful genomic services.
StudySmarter Expert Advice🤫
We think this is how you could land Design Assurance Lead
✨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 the interview by diving deep into the company’s values and recent projects. Show us how your experience aligns with their mission and how you can contribute to their quality assurance goals.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about specific situations where you've demonstrated your skills in software quality assurance and compliance.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in being part of our team.
We think you need these skills to ace Design Assurance Lead
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 at Genomics England!
Showcase Relevant Experience:Don’t just list your previous jobs; explain how your past roles have prepared you for the Design Assurance Lead position. Share specific examples of how you've contributed to quality frameworks or improved SDLC processes.
Be Clear and Concise:Keep your application straightforward and to the point. Use clear language to describe your achievements and avoid jargon unless it’s relevant to the role. We appreciate clarity as much as we value expertise!
Apply Through Our Website:We encourage you to submit your application directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team!
How to prepare for a job interview at Genomics England
✨Know Your Standards
Familiarise yourself with key standards like IEC 62304 and ISO 13485. Be ready to discuss how these frameworks apply to software quality assurance in a regulated environment, especially in healthcare. This shows you understand the importance of compliance and safety.
✨Showcase Your Collaboration Skills
Prepare examples of how you've worked with cross-functional teams, particularly engineering and QA. Highlight your ability to communicate effectively and influence stakeholders positively. This will demonstrate that you can bridge the gap between technical delivery and patient safety.
✨Emphasise Risk Management Experience
Be ready to talk about your experience with risk management activities. Discuss specific instances where you've ensured patient safety and data integrity, and how you've contributed to a Quality Management System (QMS). This is crucial for the role and will set you apart.
✨Understand the Software Development Lifecycle
Brush up on your knowledge of the Software Development Lifecycle (SDLC) and how quality assurance fits into Agile or DevOps environments. Be prepared to share insights on how you've embedded quality and compliance in past projects, as this aligns directly with the responsibilities of the role.
