Quality Manager - Orthopaedics

Guided Solutions; England; Hybrid; GBP 45,000 - 60,000; Full time

Job summary

A leading medical solutions provider in Hertfordshire is seeking a Quality Manager with experience in the Medical Devices industry. Responsibilities include creating a Quality Management System according to ISO 13485 and managing compliance for the newly established company. The role offers a hybrid working setup, combining remote work and office-based tasks. The ideal candidate will have significant expertise in ISO standards and excellent communication skills.

Qualifications

• Experience in the Medical Devices Industry as a Quality Manager.
• Knowledge of auditing processes.
• Ability to manage a Quality Management System (QMS).

Responsibilities

• Create a QMS according to ISO 13485/9001.
• Maintain UKRP Register.
• Manage the day-to-day QMS operations.
• Liaise with notified bodies for compliance.

Skills

Knowledge of ISO13485 & 9001

Experience with MDR and UKCA certification

Excellent communication skills

Problem-solving skills

Job description

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Quality Manager - Orthopaedics, Hertfordshire

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Client:

Guided Solutions

Location:

Hertfordshire, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

bc4da16c6f1a

Job Views:

22

Posted:

12.08.2025

Expiry Date:

26.09.2025

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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.