Senior Supplier QA Engineer
- Job Title: Senior Supplier QA Engineer
- Employment Status: Full-Time, Permanent
- Practice: Quality Assurance
- Location: Oxford - Hybrid
- Salary: £50,000 - £60,000
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.
This is an exciting new role within the Quality Assurance Practice to ensure all our of all medical device component suppliers meet our requirements.
Join us and help build a better future.
- Ensuring Osler’s medical device component suppliers are appropriately qualified, managed and monitored throughout the product lifecycle
- Collect, analyse, monitor and report on supplier quality metrics and key performance indicators associated with supplier capability and component quality
- Build and maintain effective supplier relationships, manage supplier feedback and coordinate resolution of supplier related non-conformances and CAPAs
- Perform routine supplier audits, identify gaps and work collaboratively to implement solutions for necessary validations, effective control of components and provision of services
- Ensure component qualification methods of suppliers are aligned with Osler’s quality standards, medical device regulations and industry best practices
- Design appropriate inspections to verify required quality standards are met
Skills & Experience :
- 8 + years experience in a Quality Assurance function within the medical device / IVD industry, specifically in a product development and manufacturing environment
- Experience working within an ISO13485 certified QMS which is aligned to FDA Quality System Requirements, with senior responsibilities and process ownership
- Demonstrable experience in supplier management for medical devices / IVDs and of writing procedures, running audits and non-conformance and CAPA processes related to suppliers
- Understanding of how to use FMEAs, MSA, SPC and PPAP tools to design supplier controls and inspections which support the entire product lifecycle
- Experience in dealing with global suppliers providing business critical components/services
- Certified ISO13485 Quality Auditor
- Experience working in organisations at different stages of growth, from small start ups to established organisations with mature QMS'
- Experience in new product development and manufacturing transfer
- Experience in using Advanced Product Quality Planning (APQP)
- Experience in providing inputs to supplier processes and equipment validations to support component quality and product compliance
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
- Yearly 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
Join us and build a better future.