QA / RA Manager - LEX Diagnostics
Cambridge, United Kingdom
LEX Diagnostics is a well-funded biotech start-up. We have a world-class medical diagnostic technology that enables rapid detection of respiratory viruses including COVID and influenza in only five minutes. The business is at a very exciting stage and we are growing rapidly as we develop and commercialise the technology internationally. You can read more about LEX here.
We are a spin-out company from TTP plc (The Technology Partnership) an established technology consulting firm with a successful track record of launching new businesses with disruptive technologies.
This role is a unique opportunity to own the creation of a Quality Management System (QMS) necessary to undertake rapid technology development to ISO 13485. As we move to clinical studies and ongoing scale-up, you will also be responsible for the expansion of the QMS to support manufacture and input into documentation for regulatory submission.
This is an intensive role which requires a careful balance between well-controlled processes and a fast pace of development. The role requires someone who values simplicity and can understand the needs of multiple stakeholders and create a solution which elegantly meets requirements.
To qualify for this role you must have:
- A Bachelor’s or Master’s degree in life sciences, engineering or related disciplines
- Proven experience of operating effectively within an ISO13485 QMS in a MedTech, pharmaceutical or biotech company
- Experience of making a significant contribution to the design, implementation and maintenance of ISO13485 QMS
- Experience of operating as an R&D scientist or R&D engineer within at least 2 different ISO13485 accredited systems
- Clear and concise written communication skills
- A rigorous approach to work with a strong eye for detail
- Ability to influence, train and mentor colleagues to ensure compliance with the QMS as it evolves.
LEX Diagnostics is part of TTP Group, an employee-owned business operating from pleasant surroundings on our own Science Park in Melbourn, South Cambridgeshire. Our working culture encourages entrepreneurship, shared ideas and technical collaboration, while providing you the freedom to do your best work. We also offer fantastic employee benefits including:
- Employer pension contribution of 12% (+3% personal contribution)
- Profit related bonus
- Enhanced share purchase scheme
- Private Medical Insurance
- Life insurance
- 25 days’ annual holiday plus bank holidays
- Discounts and memberships to local sports facilities and the theatre
- Cycle to Work scheme
- A comprehensive relocation package is also available, if applicable.