Job Description
GM Instruments and EMS Physio are seeking to recruit a Quality & Technical Manager to join our business at an exciting period of growth.
This is a key leadership role within the organisation, offering the opportunity to take ownership of the Quality Management System while driving technical excellence across our product range.
The Role
As Quality & Technical Manager, you will be responsible for the management, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring ongoing compliance with ISO 13485:2016 and the Medical Device Regulation (MDR).
You will lead the development and monitoring of key quality metrics, supporting data-driven decision making across the business. In addition, you will provide technical leadership to the engineering team, guiding product testing, validation, and development strategies across the full product portfolio.
This role requires a hands-on approach, combining strategic oversight with practical implementation.
Key Responsibilities
* Maintain and further develop the ISO 13485:2016 certified Quality Management System
* Ensure ongoing compliance with MDR and other applicable regulatory requirements
* Lead internal and external audits, including notified body and regulatory inspections
* Manage and continuously improve the CAPA system, ensuring timely and effective resolution
* Drive root cause analysis and implement robust corrective and preventive actions
* Establish and monitor key quality performance metrics across the business
* Promote a culture of quality and continuous improvement throughout the organisation
* Provide quality and regulatory guidance across product lifecycle activities, including:
* Investigations and deviations
* Change control processes
* Verification & validation activities
* SOP development and review
* Maintain Technical Files and support Post Market Surveillance activities
* Support and actively contribute to New Product Development projects
* Lead and support the engineering team in defining and executing product test and development strategies
Requirements
* Degree in Engineering or a related discipline
* Strong understanding of quality management systems within a regulated environment
* Excellent problem-solving and root cause analysis skills
* Strong organisational skills with the ability to manage multiple priorities
* Effective communicator, able to engage with stakeholders at all levels
* Demonstrated ability to influence, drive improvements, and deliver results
Experience
* Proven experience in a Quality Manager or Senior Quality Engineer role
* Minimum 2+ years’ experience within a manufacturing environment
* Strong working knowledge of ISO 13485:2016
* Practical experience with risk management in line with ISO 14971:2019
* Experience working with FDA regulations is desirable
Why Join Us?
This is an opportunity to play a pivotal role in a growing, internationally focused medical device company. You will have real influence over quality strategy, systems, and product development, working closely with leadership and cross-functional teams.
Additional Information
Please note this is an on-site role based in Irvine. Applicants must be able to reliably commute to the site and must have the right to work in the UK.
Apply
If you are looking to take the next step in your career and make a meaningful impact within a growing, internationally focused medical device company, we would love to hear from you. Please submit your CV along with details of your salary expectations.