Design Assurance Engineer

Warwick (Hybrid) or Home Based Depending on Experience

£40,000 – 45,000 + Up to 10% Bonus + Benefits

As Design Assurance Engineer you will work closely with our R&D and engineering teams to ensure that our technologies are simple, easy to use, accessible and empowering – setting people free and giving them the chance to feel like a person, rather than a patient.

Quanta Dialysis Technologies is on a mission to make dialysis accessible to every patient in every setting with its innovative QD system. With its compact size, intuitive design and GUI interface, and proven performance, QDS offers a solution that delivers powerful clinical outcomes.

Responsibilities

• Work closely with Engineering, Operations, Quality, Regulatory and Commercial Teams to facilitate design assurance.
• Generation of Product Configuration data and compilation and amendment of Device master records.
• Execution of the Transmittal process to ensure QMS documentation is transmitted, recorded, and closed.
• Support activity required for the change control, design control and regulatory compliance processes for all product/device designs.
• Assure the quality of product design from development through manufacture and commercial distribution for existing, new, and upgrade products developed by the business.
• Support Technology transfer activity- Design transfer and manufacturing transfer activity.
• International Standards compliance safety testing/reports.
• Risk management.
• Continuous design improvement.

As the ideal candidate for the role of Design Assurance Engineer you'll have:

• Manufacturing/Design/Quality Engineer (HND/Degree) with experience within a design and manufacturing environment
• Preferably experienced with Class 11 & 111 medical devices, ideally complex programmable electromechanical devices incorporating software, pneumatics, fluidics, and electronic control systems.
• Experience of Technology Transfer – product/design iteration, manufacturing process/equipment & CMO/supplier
• Experience of Design Validation & Process Validation
• Experience with Quality & risk management processes.

If you meet the criteria for Design Assurance Engineer and would like to be part of our journey, apply with a CV now. Your next career move could be just around the corner!