CK Science are recruiting for a Quality Control Instrumentation Manager to join the product assurance team with a rapidly growing research and development company in the diagnostics sector. The QC Instrumentation Manager will be working at the manufacturing site near Stirling on a full time, permanent basis.
Our client is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. This is an exciting time for them as they go through a period of growth. They are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of their dynamic and forward-looking company.
Quality Control Instrumentation Manager Role:
As the Quality Control Instrumentation Manager, you will be an integral part of the operations team. Reporting to the QC Manager, you will be responsible for running the Quality Control Instrumentation testing to ensure all system performance meets required specifications. You will work closely with the Instrumentation Manufacturing Director to improve Instrument performance and you will also have line management responsibilities for QC staff. This role will initially be focused on the development of Covid-19 testing kits before moving on to other projects.
Your main duties will be to:
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 instrumentation performance data.
Ensure sufficient capacity (people, materials, equipment) for QC is available to meet business needs.
Lead continuous improvement activities.
Ensure adherence to GxP and relevant regulatory standards including ISO13485, FDA 21CFR Part 820.
The ideal candidate for this role will have the following skills and experience:
Considerable demonstrable experience of working in the medical devices sector - essential.
Proven experience of working in and leading people in a QC environment - essential.
Able to demonstrate an in-depth experience of product testing and release procedures.
Relevant scientific background, ideally degree qualified.
Working Knowledge of Statistics.
Green Belt Certified would be beneficial.
For more information or to apply for this Quality Control Instrumentation Manager position, please contact Victoria Walker on (phone number removed) or email (url removed) , quoting job ref 49171.
It is essential that applicants hold entitlement to work in the UK.