This organisation is The Best of The Best when it comes to Medical Devices!
Enjoying their awesome facilities in Cambridgeshire and embraced by a warm, friendly culture, this is an opportunity for a Device Testing Consultant to join them for an initial period of 6 months which, hopefully, will lead to a permanent contract.
They've won several awards for their contributions to cutting-edge medical device technology, supporting both start-ups and large pharma companies. They're situated close to the M11 with easy access by road and rail between both Cambridge and London.
The team is currently 16 strong and work on a wide variety of medical devices. Joining them, your job will be to share your testing expertise within their well-equipped test labs. This will also include supporting the preparation and review of test documents, regularly reporting on and presenting your work to customers.
You'll need to work to the highest quality and compliance standards to deliver the complete package needed to support regulatory submissions.
This position is urgent, so we're keen to hear from you ASAP.
The Role, in a nutshell…
- Planning and delivering test work for projects
- Authoring and reviewing technical documents
- Following the Quality Management System requirements for testing and data integrity
- Interpreting complex test requirements and coming up with a test solution
- Collaborating with project teams to develop test approaches, implement solutions and deliver test programmes, whilst identifying key resources for the projects' needs
- Helping with technical investigations to identify root causes and drive resolutions
You should apply if you…
- Have experience planning, overseeing and delivering a testing programme for medical products
- Have detailed knowledge of testing methodologies for mechanical functions of drug delivery devices, ideally inhalers
- Know how to use data analysis tools including statistical methods
- Can demonstrate a track record of developing and implementing complex or novel testing methodologies
- Have some working experience of ISO standards and industry guidance for device testing, including Design Verification
- Have worked within a quality management system, following principles such as cGxP, ALCOA and data integrity
- Can communicate and present clearly and concisely
What else would be brilliant, but not essential?
- Experience contributing to risk management activities (e.g. FMEA)
- Working knowledge of test method and equipment verification and validation best practices (e.g. Gauge R&R, IQ/OQ/PQ, FAT, SAT)
- Minitab statistical software experience
- Experience within a consulting environment
- Line management experience
What's on offer?
- 9% contributory pension
- Profit share scheme
- Private Medical and Employee Assistance Programme
- Rising holiday, starting at 26 days + bank holidays - you can also top-up!
- months unpaid sabbatical available after 5 years life insurance 4 x annual salary
- Income protection
- Cycle to work scheme, with a heated bike shed!
- Social activities
- Hybrid working