Who is our client?
Our client are a family owned business who have been established for over 25 years, they are a leading global expert in a range of Consumable Medical devices, they have an impressive presence in both the UK and Europe. There products are used in both hospitals and clinics, they have a true passion for supporting their patients and their families.They have an exceptional reputation for both product quality and service.
Due to continued expansion, our client are now looking to take on a Quality Engineer to work closely with the Technical Manager.
The role requirements
Quality Management System updates following changes to procedures and work instructions.
Technical File updates following changes to software, drawings or component specification.
Provide international customer help desk complaints and technical support
Management breakdown and associated quality system requirements.
Participate in Notified Body audits.
Establish appropriate quality checks on incoming and outgoing goods
Provide statistical analysis to appropriate personnel regarding the quality of incoming components
Work with sales, purchasing, and production, as well as liaising with component suppliers.
Perform necessary inspections to ensure training evaluation and process validation.
Liaising with other sections in Product Development
Prepare reports by collecting, analysing, and summarising data; making recommendations.
What sort of people are we looking for?
Quality or Engineering related qualifications (HNC/Degree).
Understanding and experience of working to ISO 13485 and 60601.
Experience with Class 2a devices.
Willing to learn all aspects of company processes..
Methodical and meticulous in approach.
An effective communicator and a good team player.
Conscientious with a self-disciplined approach.
Motivated and flexible.