Quality Systems Engineer (NPD, Medical Devices)

Cardiff, Bristol

c£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 steady growth they now have an immediate requirement for a medical devices Quality Systems Engineer to provide support for design/development and manufacture, specifically, for carrying out quality control processes and the generation and/or review and approval of associated records and ensuring compliance with the requirements of ISO 13485:2016 and US FDA quality system regulation.

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.

Experience

• Quality Engineering, Quality Assurance or Regulatory role in class II or class III medical devices environment.
• 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.
• Subject matter expert for ISO 13485 and/or FDA 21 CFR part 820, BS EN 14971.
• Working knowledge of ISO 10993, IEC 60601 ISO 11137 desirable.
• An understanding of process validation, process control and statistics cleanroom manufacturer, electronics manufacturing techniques desirable.
• Proactive with a sense of urgency - make things happen/get results

Qualifications

Degree qualified in an engineering or equivalent experience