At a Glance
- Tasks: Lead software quality assurance processes to ensure safe and impactful digital services.
- Company: Join Genomics England, a leader in healthcare innovation.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Work in a dynamic environment with offices in Cambridge, Leeds, and London.
- Why this job: Shape the future of healthcare technology while ensuring patient safety and compliance.
- Qualifications: Experience in software quality assurance and knowledge of medical device regulations.
The predicted salary is between 60000 - 80000 € 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.
Design Assurance Lead (Software/SaMD)(we have office locations in Cambridge, Leeds and London) [...] employer: Genomics England Limited
At Genomics England, we pride ourselves on being an exceptional employer, offering a collaborative and innovative work culture that empowers our employees to drive meaningful change in healthcare. With offices in Cambridge, Leeds, and London, we provide ample opportunities for professional growth and development, alongside a commitment to maintaining a healthy work-life balance. Join us to be part of a forward-thinking team dedicated to enhancing software quality assurance in a dynamic and impactful environment.
StudySmarter Expert Advice🤫
We think this is how you could land Design Assurance Lead (Software/SaMD)(we have office locations in Cambridge, Leeds and London) [...]
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend meetups, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their approach to software quality assurance and be ready to discuss how your experience aligns with their goals. Show them you’re not just another candidate!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality frameworks and compliance standards. We want you to feel confident and articulate when discussing your expertise in software as a medical device.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Genomics England.
We think you need these skills to ace Design Assurance Lead (Software/SaMD)(we have office locations in Cambridge, Leeds and London) [...]
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Design Assurance Lead role. Highlight your experience in software quality assurance and any relevant projects that align with the responsibilities mentioned in the job description.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in healthcare and how your skills can help us drive excellence at Genomics England.
Showcase Relevant Experience:When filling out your application, be sure to showcase your experience with software development lifecycles and compliance with standards like IEC 62304. We want to see how you’ve contributed to safe and reliable software delivery.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Genomics England Limited
✨Know Your Standards
Familiarise yourself with key standards like IEC 62304 and UK Medical Device Regulations. Be ready to discuss how these standards influence software quality assurance processes and how you can ensure compliance in your role.
✨Showcase Your Experience
Prepare specific examples from your past work where you've successfully led quality assurance initiatives. Highlight how you shaped quality frameworks or improved the Software Development Lifecycle (SDLC) in a previous role.
✨Understand the Healthcare Environment
Brush up on the unique challenges of delivering software in a data-driven healthcare setting. Be prepared to discuss how you would address patient safety, data integrity, and regulatory compliance in your approach to quality assurance.
✨Collaborative Mindset
Emphasise your ability to partner with engineering, software QA, and QIRA teams. Share examples of how you've effectively communicated quality requirements and fostered collaboration to achieve project goals.
