Quality Assurance Specialist - Cambridge

TN United Kingdom; Cambridge; Hybrid; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is looking for a Quality Assurance Specialist in Cambridge to join their growing Medical Devices team. This exciting role involves developing a robust Quality Management System in line with ISO 13485 standards. You will create and manage technical files for diverse Medical Devices while collaborating with experts in the field. This position is ideal for candidates with experience in ISO 9001 or QMS, offering a pathway into the Medical Devices sector. The role starts with a daily office presence, transitioning to hybrid work as the QMS matures. Don’t miss this opportunity to make a significant impact in a dynamic environment.

Qualifications

• Experience in ISO 9001 or QMS is required.
• Understanding of Regulatory Affairs is advantageous.

Responsibilities

• Assist in developing the Quality Management System in compliance with ISO 13485.
• Create and manage technical files for various Medical Devices.

Skills

ISO 13485

Quality Management System (QMS)

ISO 9001

Regulatory Affairs

Education

Degree in Quality Assurance

Degree in Quality Engineering

Degree in Design Assurance

Job description

Quality Assurance Specialist - Cambridge, Cambridge

Client: Newton Colmore Consulting Ltd

Location: Cambridge, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 44675ad159b5

Job Views: 4

Posted: 24.04.2025

Expiry Date: 08.06.2025

Job Description:

We are seeking a Quality Assurance Specialist in Cambridge for a growing Medical Devices company. The role involves assisting in the development of the Quality Management System (QMS) in compliance with ISO 13485 standards. Candidates from alternative sectors with ISO 13485 training are encouraged to apply.

Your responsibilities will include creating and managing technical files for various Medical Devices, including Class I, Class IIa, and Class IIb devices. You will work closely with Medical Devices experts, primarily focusing on Quality Assurance, with support from the parent company's QA Manager.

This position is suitable for candidates with a few years of experience in ISO 9001 or QMS, as well as more experienced professionals seeking to lead QMS development or transition into the Medical Devices sector under ISO 13485 standards. Due to active QMS setup, daily presence in the office is required initially, with potential for hybrid working over time.

The ideal candidate will have a degree related to Quality Assurance, Quality Engineering, or Design Assurance. A good understanding of Regulatory Affairs is advantageous. Experience working alongside manufacturing teams in Medical Devices QA, especially from a Quality Engineering background, is desirable but not essential.

Interested candidates are encouraged to apply promptly to avoid missing out. For more information, contact Andrew Welsh, Director of Medical Devices Recruitment at Newton Colmore Consulting, at [phone], or submit an application to be contacted by our team.