Senior Software Design Quality Assurance Engineer
Job Title: Senior Software Design Quality Assurance Engineer
Employment Status: Full-Time, Permanent
Practice: Quality Assurance
Location: Oxford
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 realizing 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:
1. A depth of experience in a highly regulated industry, within quality or software development functions, with ownership of software development quality assurance
2. Experience working with BS EN 62304, ISO 14971, ISO 13485, FDA (21 CFR Part 820, 21 CFR Part 11), UK & EU regulations
3. Experience in the application of risk-based methodologies in the oversight of product software development
4. Experience working with multidisciplinary teams on new product introduction projects
5. Experience in project management and planning following both Agile and Waterfall methodologies
6. Experience working in the Medical Device and or IVD industry
7. Experience in software documentation for US regulatory submissions (i.e. 510(k))
8. Generation of quality documentation including standard operating procedures, design history documentation, protocols and reports
9. Qualified auditor to BSI standard (or equivalent)
10. Experience of participating in and supporting regulatory audits
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.
1. 25 days holiday + bank holidays and a Christmas closure
2. Annual Learning & Development budget 4% of your salary
3. 12 days of Learning leave
4. £500 Well-being allowance
5. Private Medical Insurance - (includes subsidised gym memberships)
6. 24/7 access to a GP
7. Life Assurance - x4 annual salary
8. Income Protection - 75% of your basic annual salary
9. Private Travel Insurance
10. Annual eye tests
11. Travel to work loan scheme
12. Relocation assistance
13. Volunteering leave
14. Give as you earn - pre-tax salary donations to any UK charitable organisation.
15. Quarterly Team Building events and social events
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