Design Assurance Lead (Software/SaMD)(we have office locations in Cambridge at Genomics England

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

09 Aug, 26

Salary

75000.0

Posted On

11 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software Quality Assurance, Design Assurance, Regulatory Compliance, Risk Management, SDLC Governance, Requirements Management, Verification and Validation, IEC 62304, ISO 13485, ISO 14971, Agile, DevOps, Stakeholder Engagement, Quality Management Systems, SaMD, UK MDR

Industry

Biotechnology Research

Description

Company Description Genomics England is a global leader in enabling genomic medicine and research, focused on creating a world where everyone benefits from genomic healthcare. Building on the 100,000 Genomes Project, we support the NHS’s world-first national whole genome sequencing service and run the growing National Genomic Research Library, alongside delivering numerous major genomics initiatives. By connecting research and clinical care at national scale, we enable immediate healthcare benefits and advances for the future. Our mission is to provide the evidence and digital systems so that by 2035 genomics could play a role in up to half of all healthcare interactions, whilst securing the UK’s position as the best place to discover, prove and benefit from genomic innovations. We are accelerating our impact and working with patients, doctors, scientists, government and industry to improve genomic testing, and help researchers access the health data and technology they need to make new medical discoveries and create more effective, targeted medicines for everybody. Behind the Healthcare and Research outcomes, Genomics England delivers through designing, developing and operating complex healthcare software systems. We're on the cusp of big changes with the real prospect of genomics becoming the fabric of everyday healthcare through the lifetime – from birth to old age. Job Description 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. Everyday responsibilities include: 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 for success: 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. Qualifications MSc/BSc Degree in Engineering, Quality, Architecture, Design or equivalent. Additional Information Salary from: £75,000 Closing date for applications - Monday 1st June Being an integral part of such a meaningful mission is extremely rewarding in itself, but in order to support our people, we’re continually improving our benefits package. We pride ourselves on investing in our people and supporting them to achieve their career goals, as well as offering a benefits package including: 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 and our commitment to a diverse and inclusive workplace Genomics England is actively committed to providing and supporting an inclusive environment that promotes equity, diversity and inclusion best practice both 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 and 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. Culture We have four key behaviours that represent what we would like Genomics England to feel like and the culture we want to encourage, in order for us to achieve our mission. These behaviours help us all work well together, deliver on our outcomes, celebrate our successes and share feedback with each other. You can read about these and other aspects of our culture here Culture | Genomics England Blended working model Genomics England operates a blended working model as we know our people appreciate the flexibility that hybrid working can bring. We expect most people to come into the office a minimum of 2 times each month. However, this will vary according to role and will be agreed with your team leader. There is no expectation that people will return to the office full time unless they want to, however, some of our roles require full time on site attendance e.g., lab teams, reception team. Our teams and squads have, and will continue to reflect on what works best for them to work together successfully and have the freedom to design working patterns to suit, beyond the minimum. Our office locations are: Canary Wharf, Cambridge and Leeds. Onboarding background checks As part of our recruitment process, all successful candidates are subject to a Standard Disclosure and Barring Service (DBS) check. We therefore require applicants to disclose any previous offences at point of application, as some unspent convictions may mean we are unable to proceed with your application due to the nature of our work in healthcare. Department: Quality, Improvement and Regulations Office: London

Responsibilities

Lead and evolve software quality assurance processes to ensure safe and compliant digital genomic services. Drive compliance with UK Medical Device Regulations and standards like IEC 62304 across Software as a Medical Device solutions.