£40k - £45k
Our client is an innovative medical device company specialising in the design and development of cutting edge electro-mechanical medical devices and due to continued growth they now have an immediate requirement for a medical devices Quality Engineer to provide quality engineering support to design and manufacture and the generation of documentation ensuring compliance with the requirements of ISO 13485 and US FDA regulations.
The role is essential to ensuring products are designed, developed and manufactured to a high quality and to supporting compliance to regulatory requirements. The role requires close and proactive working with design/development engineers and technicians, production, purchasing and materials control personnel.
It would be suitable for a Quality Engineer with experience of a highly regulated industry such as automotive, aerospace, defence, nuclear or medical seeking to progress or begin a career in medical devices.
- Supporting new product development teams through the regulatory pathway to release to market in the US or Europe.
- Technical file documentation and ensuring that teams are operating to the quality system and regulatory requirements.
- An understanding of process validation, process control and statistics cleanroom manufacturer, electronics manufacturing techniques desirable.
- Working knowledge of medical devices or other highly regulated industry standards
Desirable or willing to acquire the following medical devices quality experience
- Subject matter expert for medical devices standards
- Quality Engineering and Assurance with class II or class III medical devices environment.
Degree qualified in an engineering or equivalent experience
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