QC director - IVD Medical Device
Fastest Growing IVD Organization in EU
Own the QC department
About Our Client
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx currently has over 1200 employees worldwide.
We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
- Set Up the QC laboratory at the Glasgow Site.
- Develop the strategy for the testing and release of test strip lots to ensure schedules are adhered to.
- Integrate automated data analysis for the QC test methods.
- Ensure effective New Product Transfer from R&D into QC.
- Develop a strategy for reporting product performance data in real time.
- Develop and manage the resource strategy (people, materials, equipment, storage ) for QC group.
- Introduce relevant KPI's and regular reporting to support a culture of continuous improvement.
- Achieve QC business targets within a rapidly growing business.
- Test Method Validation (TMV) development and deployment.
- Some lab equipment validation.
The Successful Applicant
Able to demonstrate a knowledge of Statistics.
Able to demonstrate an in-depth experience of working in medical devices.
Background in Science/Engineering with experience of leading a QC function.
Proven Track record of people development.
Proven track record of problem solving.
What's on Offer
Competitive Salary Package at Director Level + Benefit + Bonus