Quality Control Manager
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 450 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.
Role & Responsibilities
Due to growth we are looking for an experienced Quality Control Manager with a Medical Device background to join our Operations team on a full-time, permanent basis.
Reporting to the Operations Director, you will be responsible for the implementation, validation and improvement of Product Release test methods for the key system components. You will also lead and develop the Quality Control team.
- Review and Improve existing Quality Control test methods and release procedures.
- Ensure effective New Product Transfer from R&D into Quality Control.
- Develop a system for trending and reporting of product performance data.
- Ensure sufficient capacity (people, materials, equipment) for Quality Control is available to meet business needs.
- Lead continuous improvement activities to improve performance and reduce Cost of Goods.
- Ensure adherence to GxP and relevant regulatory standards including ISO13485, FDA 21CFR Part 820.
- Create a working environment which acknowledges and pro-actively supports compliance with GMP.
- Work collaboratively with relevant employees and customers with an awareness of cultural differences.
- Prepare and present needs of your team and ensure they are met.
We are looking for a highly motivated individual that can demonstrate flexibility and a can do attitude along with the following:
- Background in Science/Engineering with experience of working in a Quality Control environment.
- Able to demonstrate an in-depth knowledge of Statistics.
- In-depth experience of working in Medical Devices.
- Proven Track record of people development.
- Proven track record of problem solving.
- Black or Green Belt Certified.
- Able to demonstrate an in-depth experience of product calibration.
For further information and to apply for this role, please click APPLYAPPLY