Quality Manager - Orthopaedics

Guided Solutions; England; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A medical devices firm in the UK is seeking a Quality Manager to develop their Quality Management System in accordance with ISO 13485. This role involves both remote and office-based responsibilities, with key tasks including managing internal audits and ensuring compliance with regulatory standards. Candidates should have proven experience in the Medical Devices Industry and a strong understanding of quality management processes.

Qualifications

• Experience in the Medical Devices Industry is essential.
• Previous experience as a Quality Manager is required.
• Self-motivated individuals with a positive attitude are preferred.

Responsibilities

• Create a Quality Management System according to ISO 13485/9001.
• Manage daily operations of the Quality Management System.
• Liaise with overseas manufacturers/contractors for compliance.
• Carry out audits and ensure documentation accuracy.

Skills

Knowledge of ISO13485 & 9001

Knowledge of MDR and UKCA certification

Excellent communication skills

Problem-solving skills

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.