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- Tasks: Lead software quality assurance to ensure compliant product development.
- Company: Join Osler, a pioneering UK diagnostics company transforming health access globally.
- Benefits: Enjoy 25 days holiday, private medical insurance, and a well-being allowance.
- Other info: Flexible working options and opportunities for professional growth await you.
- Why this job: Be part of a mission-driven team making a real impact on global health.
- Qualifications: Experience in regulated industries and software development quality assurance is essential.
The predicted salary is between 43200 - 72000 £ per year.
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Senior Software Design Quality Assurance Engineer, Oxford
Client:
Osler
Location:
Oxford, United Kingdom
Job Category:
Other
EU work permit required: Yes
Job Reference:
17f2f540db76
Job Views:
10
Posted:
18.07.2025
Expiry Date:
01.09.2025
Job Description:
Company:
Do you want to make a difference while advancing your career? Come join Osler.
We are a UK diagnostics company whose purpose is to enable anyone, anywhere, to access, understand, and act on their health, to live healthier, happier, and longer lives.
We are realising this through the development of the Osler Origin – a \’portable lab\’ capable of performing a wide range of testing, with lab-quality performance, in a portable, rapid, low-cost, and easy-to-use manner. The Osler Origin will offer a wide portfolio of diagnostic tests and serve all major healthcare settings, globally.
The Osler Origin is powered by a portfolio of novel techniques and approaches for sample addition, microfluidic sample preparation, and electrochemical biosensing, and Osler was formed out of the University of Oxford in 2017, following decades of research.
Having recently completed an $85m Series C fundraise, we are now entering a growth phase, where we are scaling our team as we take the Osler Origin product through regulatory activities, and towards market launch.
We are now recruiting for Senior Design QA Engineer based in Oxford to ensure compliant product software development throughout the product development lifecycle.
Join us and help build a better future.
Key Responsibilities:
- Accountable for compliant product software development in accordance with Osler procedures and IVD regulatory standards
- Lead software quality assurance activities, with accountability for establishing and maintaining compliance for product software
- Author and guide creation of procedures, design control documentation, test protocols and reports supporting and documenting product software development
- Work collaboratively with product development teams to deliver verified and validated product through hands on work and subject matter guidance
- Drive a risk based approach to software development
Skills & Experience:
Essential
- A depth of experience in a highly regulated industry, within quality or software development functions, with ownership of software development quality assurance
- Experience working with BS EN 62304, ISO 14971, ISO 13485, FDA (21 CFR Part 820, 21 CFR Part 11), UK & EU regulations
- Experience in the application of risk-based methodologies in the oversight of product software development
- Experience working with multidisciplinary teams on new product introduction projects
- Experience in project management and planning following both Agile and Waterfall methodologies
Desirable
- Experience working in the Medical Device and or IVD industry
- Experience in software documentation for US regulatory submissions (i.e. 510(k))
- Generation of quality documentation including standard operating procedures, design history documentation, protocols and reports
- Qualified auditor to BSI standard (or equivalent)
- Experience of participating in and supporting regulatory audits
Benefits:
We offer a competitive benefits package, with a focus on health and well-being – further supporting the belief in our mission to enable anyone, anywhere, to access, understand and act on their health.
- 25 days holiday + bank holidays and a Christmas closure
- Annual Learning & Development budget 4% of your salary
- 12 days of Learning leave
- 4% matched pension
- £500 Well-being allowance
- Private Medical Insurance – (includes subsidised gym memberships)
- 24/7 access to a GP
- Life Assurance – x4 annual salary
- Income Protection – 75% of your basic annual salary
- Private Travel Insurance
- Annual eye tests
- Cycle-to-work scheme
- Travel to work loan scheme
- Relocation assistance
- Volunteering leave
- Give as you earn – pre-tax salary donations to any UK charitable organisation.
- Quarterly Team Building events and social events
- Enhanced maternity/paternity
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Senior Software Design Quality Assurance Engineer employer: Osler
Contact Detail:
Osler Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Software Design Quality Assurance Engineer
✨Tip Number 1
Familiarise yourself with the specific regulatory standards mentioned in the job description, such as BS EN 62304 and ISO 13485. Understanding these standards will not only help you in interviews but also demonstrate your commitment to compliance in software development.
✨Tip Number 2
Network with professionals in the medical device and diagnostics industry. Attend relevant conferences or webinars where you can meet people from Osler or similar companies. This can provide you with insider knowledge and potentially a referral.
✨Tip Number 3
Prepare to discuss your experience with both Agile and Waterfall methodologies. Be ready to share specific examples of how you've successfully managed projects using these approaches, as this is crucial for the role.
✨Tip Number 4
Showcase your ability to work collaboratively with multidisciplinary teams. Think of examples where you've contributed to product development alongside engineers, designers, and regulatory experts, as teamwork is key in this position.
We think you need these skills to ace Senior Software Design Quality Assurance Engineer
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Senior Software Design Quality Assurance Engineer position. Make sure you understand the key responsibilities and required skills, particularly in relation to regulatory standards and software development methodologies.
Tailor Your CV: Customise your CV to highlight relevant experience in quality assurance and software development, especially in regulated industries. Emphasise your familiarity with standards like BS EN 62304 and ISO 13485, as well as any project management experience you have.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the mission of Osler. Discuss how your skills can contribute to their goal of making healthcare accessible and how your experience aligns with their product development lifecycle.
Proofread and Edit: Before submitting your application, carefully proofread your documents. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at Osler
✨Understand Regulatory Standards
Familiarise yourself with key regulatory standards such as BS EN 62304, ISO 14971, and FDA regulations. Being able to discuss how these apply to software development in a medical context will show your depth of knowledge and relevance to the role.
✨Showcase Your Experience
Prepare to discuss specific examples from your past work that demonstrate your experience in quality assurance within regulated industries. Highlight any projects where you led software quality assurance activities or worked on new product introductions.
✨Emphasise Collaboration Skills
Since the role involves working with multidisciplinary teams, be ready to share examples of how you've successfully collaborated with others. Discuss your approach to teamwork and how you ensure effective communication across different functions.
✨Prepare for Risk-Based Methodologies
Be prepared to explain your understanding and application of risk-based methodologies in software development. Discuss how you've implemented these approaches in previous roles and the impact they had on project outcomes.