Quality Manager - Orthopaedics

Our client's expertise lies in delivering cutting-edge osteosynthesis solutions to the orthopaedic sector, with a strong focus on extremities and fragility fractures across the skeletal system.

Due to their continued growth, they are looking for a Quality Manager with experience in the Medical Devices Industry. Their main duty will be to create the Quality Management System (ISO 13485) as well as help with other quality / regulatory requirements – UKRP, HTA, MSAT, Carbon Reduction plans, GDPR etc.

The role will be a mixture of remote working as well as office-based when needed.

Key responsibilities

• Creating a QMS for a newly established company according to ISO 13485 / 9001.
• Keeping UKRP Register up to date.
• Helping to write new policies GDPR / MSAT.
• Managing the Quality Management system day to day, doing internal audits, liaising with notified bodies etc.
• Checking technical files.
• Liaising...