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:
1. Accountable for compliant product software development in accordance with Osler procedures and IVD regulatory standards
2. Lead software quality assurance activities, with accountability for establishing and maintaining compliance for product software
3. Author and guide creation of procedures, design control documentation, test protocols and reports supporting and documenting product software development
4. Work collaboratively with product development teams to deliver verified and validated product through hands on work and subject matter guidance
5. Drive a risk based approach to software development
Skills & Experience:
Essential
6. A depth of experience in a highly regulated industry, within quality or software development functions, with ownership of software development quality assurance
7. Experience working with BS EN 62304, ISO 14971, ISO 13485, FDA (21 CFR Part 820, 21 CFR Part 11), UK & EU regulations
8. Experience in the application of risk-based methodologies in the oversight of product software development
9. Experience working with multidisciplinary teams on new product introduction projects
10. Experience in project management and planning following both Agile and Waterfall methodologies
Desirable
11. Experience working in the Medical Device and or IVD industry
12. Experience in software documentation for US regulatory submissions (i.e. 510(k))
13. Generation of quality documentation including standard operating procedures, design history documentation, protocols and reports
14. Qualified auditor to BSI standard (or equivalent)
15. 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.
16. 25 days holiday + bank holidays and a Christmas closure
17. Annual Learning & Development budget 4% of your salary
18. 12 days of Learning leave
19. 4% matched pension
20. £500 Well-being allowance
21. Private Medical Insurance - (includes subsidised gym memberships)
22. 24/7 access to a GP
23. Life Assurance - x4 annual salary
24. Income Protection - 75% of your basic annual salary
25. Private Travel Insurance
26. Annual eye tests
27. Cycle-to-work scheme
28. Travel to work loan scheme
29. Relocation assistance
30. Volunteering leave
31. Give as you earn - pre-tax salary donations to any UK charitable organisation.
32. Quarterly Team Building events and social events
33. Enhanced maternity/paternity