Senior QA Engineer
Job Title: Senior Quality Assurance Engineer
Employment Status: Full Time, Perm
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.
Join us and help build a better future.
- Work collaboratively with the product development team to provide quality assurance in design and development of medical devices.
- Provide expert guidance to ensure products and associated design and development processes are compliant with required standards for design and development of medical devices and risk management as per ISO 13485, ISO14971, 21CFR820 and other applicable regulatory requirements.
- Act as a quality assurance representative for the creation and approval of product development documents and design history records such as requirements, design outputs and design verification and validation deliverables.
- Partner with product development and technology transfer teams and provide quality support on risk management activities for risk management plans, hazard analysis, dFMEAs and pFMEAs in compliance with the requirements of ISO14971.
- Identify and address gaps related to all aspects of product Quality and compliance for the design and development.
Skills, Experience, & Attributes:
- 10+ years’ experience in quality engineering role of medical device or IVD products.
- Working knowledge of the application of FDA Quality System Regulation, 21CFR820, 21CFR809, ISO 13485 Quality system standards for medical device and ISO14971 Risk Management Systems to product development and manufacture Hands on quality engineering experience in new product design and development and manufacturing.
- Experience of writing, reviewing and approving design and development documentation and processes.
- Experience of working within and of maintaining an ISO 13485 certified QMS.
- Desirable skills/experience.
- Experience of participating in and supporting regulatory audits.
- Experience of working with multidisciplinary development teams.
- Experience in preparing for regulatory submissions for UK, EU and US markets.
- Experience in a startup or small business environment.
- Qualified auditor to BSI standard (or equivalent).
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.
There is no perfect candidate, and no single person can do it all, but if this sounds like you, or what you could be and you're looking for somewhere to thrive; we want to hear from you.
We look forward to receiving your application. If you have any questions, please contact email@example.com
Join us and build a better future.