Job Description
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 with overseas manufacturers/contractors to ensure compliance. Carry out and assist with audits throughout the business. Ensure procedures are in place and associated documentation is correct. Oversee the implementation of an electronic document management system. To be considered for the role, you must closely match the following criteria: Knowledge of ISO13485 & 9001 within Medical Devices Knowledge of MDR and UKCA certification (technical files) Previous experience as a Quality Manager Have previous experience of the auditing process. Capable of fully managing a QMS. Have excellent communication skills both verbal and written. Be self-motivated and have a positive attitude. Good problem-solving skills. If you are interested in this position, please provide an up-to-date CV as soon as possible, along with your availability and your salary expectation.