Quality Assurance Specialist – Cambridge

Newton Colmore Consulting Ltd; United Kingdom; On-site; GBP 30,000 - 45,000; Full time

Job summary

A medical devices consulting firm based in Cambridge is seeking a Quality Assurance Specialist to develop and manage a QMS system for ISO 13485 standards. The role includes creating technical files for various Medical Devices and collaborating with experienced professionals. Ideal for candidates with a degree related to Quality Assurance and those eager to build a career in the Medical Devices sector. There is potential for hybrid work as the role evolves.

Qualifications

• Experience in ISO 9001 or QMS, with willingness to train for ISO 13485.
• Background in Quality Assurance or Quality Engineering.
• Experience in Medical Devices Quality Assurance is advantageous.

Responsibilities

• Assist in the development of the QMS system for ISO 13485 standards.
• Create and manage technical files for Medical Devices lines.
• Collaborate with Medical Devices experts while focusing on Quality Assurance.

Skills

ISO 13485 standards training

Quality Assurance background

Understanding of Regulatory Affairs

Education

Degree in Quality Assurance, Quality Engineering, or Design Assurance

Job description

Quality Assurance Specialist – Cambridge

A growing Medical Devices company based in Cambridge is currently looking for a new Quality Assurance Specialist to assist in the development of the QMS system for ISO 13485 standards. They are open to candidates from alternative sectors, allowing for ISO 13485 standards training.

You will also be creating and managing technical files for several Medical Devices lines, including Class I, Class IIa and Class IIb Medical Devices. You’ll collaborate with a number of Medical Devices experts, but you will be the sole person focusing on Quality Assurance duties. However, you will receive Quality Assurance assistance from the parent company’s Quality Assurance Manager. Due to this, we are open to candidates who only have a couple of years of experience of ISO 9001 or QMS, but also keen to hear from people with more experience.

This is an excellent opportunity for someone a couple of years into their career and looking for more responsibility to lead the development of a QMS system, or for someone who is looking for a route into the Medical Devices sector under ISO 13485 standards. Due to the active work in setting up the QMS system, you will need to be in the office daily; however, over time there should be the opportunity for hybrid working.

It is expected that you would hold a degree in a subject that has led you into a Quality Assurance, Quality Engineering, or Design Assurance role.

Apart from having a Quality Assurance background, it would also be highly advantageous if you have a good understanding of Regulatory Affairs.

Part of your role will involve working alongside the manufacturing teams for these medical devices. Due to this, it would be highly beneficial if your Medical Devices Quality Assurance experience came from a Quality Engineering background, although this is not essential.

I anticipate a lot of interest in this role, so if you are interested, I suggest making an application now or risk missing out.

For more information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment, Science recruitment and Biotech recruitment specialists Newton Colmore Consulting, on [phone] or make an application and one of our team at Newton Colmore Consulting will contact you.