Quality Control Strip Calibration Testing Manager
Alloa, Glasgow, UK
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 is a high growth organisation. 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
This role could be based at our site in Stirling OR Glasgow and travel between both sites may be required.
As an integral part of the Operations team, reporting to the QC Manager, you will be responsible for running the Quality Control Strip Calibration testing to ensure strip performance meets required specifications for multiple products.
You will be responsible for managing the strip testing schedule to meet business needs and the implementation, validation and improvement of Calibration Release test methods. You will work closely with both the Product Assurance team and R&D project teams to improve strip performance. You will have line management responsibilities for a QC sampling technician.
Key Areas of Responsibility
- Manage the Strip Testing schedule and report daily progress
- Review and Improve existing QC test methods and release procedures
- Ensure effective New Product Transfer from R&D into QC
- Develop a system for trending and reporting of Strip performance data
- Lead continuous improvement activities to simplify processes, improve performance and reduce Cost of Goods.
- Automation of Data Capture and Analysis
- Review and Approval of Calibration Batch Records
- 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.
- Able to demonstrate experience of working in medical devices.
- Background in Science/Engineering with experience of working in a QC environment.
- Working Knowledge of Statistics.
- Proven Track record of people development.
- Proven track record of problem solving.
- Able to demonstrate an in-depth experience of product testing and release procedures would be advantageous.
- Green Belt Certified would be beneficial but not essential.
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
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