Looking for a QARA position that doesn't see you pigeonholed into one area?
Our client, a dynamic and innovative organisation in the medical device industry, is seeking a skilled QARA Specialist to join their team.
With the chance to work on cutting-edge products and contribute to the improvement of global healthcare, this is a role that offers both professional growth and personal fulfilment.
Day to day will see you:
Work closely with the QARA manager to maintain and monitor the QMS.
Support activities across document control, CAPA, supplier management and internal audits.
Generate trend analysis reports to identify KPI's for critical products and processes.
Lead risk management activities across the product lifecycle in accordance with ISO 14971
Provide support on global regulatory submissions (IVDR, CE and FDA) keeping technical files up to date. A little more info:
The role will be hybrid, with home working 3-4 days per week and the remainder onsite in Newquay.
Given the nature of the product, IVD, IEC 62304, IEC 62366, ISO 60601 or IEC 61010 would be highly desirable.
We need to see a minimum of 3 years working in a quality assurance role.
As a small organisation of around 10 and still eager to create new products, experience in new product development, design controls and design transfer processes would be ideal.
If you thrive in a challenging environment, where your contributions truly make a difference, then this is the opportunity for you.
Please apply with an up to date CV and we will be in touch