Job Summary
ProAxsis Ltd is a commercial diagnostics company with growing sales of its laboratory-based and point-of-care in vitro diagnostic (IVD) products. We are looking to recruit a Quality Specialist to join our dynamic team. You will support with implementation, maintenance and continual improvement of our Quality Management System, and work closely with staff to promote a quality culture and ensure understanding of Quality Systems.
Responsibilities/Key Duties
· Implementation and maintenance of a ISO13485:2016 and GCLP compliant Quality Management System.
· Day to day management of quality management system activities e.g. document control, change control, CAPA, validation, audits, customer complaints and supplier management.
· Supporting the Quality Assurance & Regulatory Consultant with regulatory activities including vigilance, post-market surveillance, regulatory intelligence and maintenance of technical documentation.
· Promote the development of a ‘Quality Culture’.
· Plan own day-to-day activities within framework of ongoing work.
· Partner with the Quality Assurance & Regulatory Consultant and the Head of Business Operations to achieve short- and long-term Quality Management System goals.
· Liaise on a regular basis with other ProAxsis team members.
· Have regular 1:1 and wider team meetings with the Head of Business Operations to provide updates and discuss any issues/challenges which have arisen.
· Proactively support and assist where necessary other Business Operations areas to ensure wider group goals are achieved.
· Where necessary provide training to others.
