Quality Assurance Specialist - Cambridge)

Newton Colmore Consulting; Cambridge; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player in the Medical Devices sector is seeking a Quality Assurance Specialist in Cambridge. This role offers an exciting opportunity to develop and manage a Quality Management System (QMS) under ISO 13485 standards. You will be responsible for creating technical files for various Medical Devices, collaborating with experts, and leading Quality Assurance efforts. Ideal for candidates seeking to advance their careers in Quality Assurance, this position encourages growth and offers the potential for hybrid working arrangements in the future. If you are ready to take on more responsibility and make a significant impact, this opportunity is perfect for you.

Qualifications

• Degree in a related field leading to Quality Assurance roles.
• Experience with ISO 9001 or QMS is beneficial.

Responsibilities

• Develop and manage the QMS system for ISO 13485 standards.
• Create technical files for various Medical Devices lines.
• Collaborate with Medical Devices experts on Quality Assurance.

Skills

ISO 13485

Quality Assurance

Regulatory Affairs

Quality Engineering

ISO 9001

Education

Degree in Quality Assurance or related field

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.