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Quality Assurance Engineer - ISO 13485 - Cambridge

Cambridgeshire   •  Negotiable  •  Permanent, Full time

Quality Assurance Engineer - ISO 13485 - Cambridge

Due to the recent growth of a small medical devices company in Cambridge there is currently need for at least three well experienced Quality Assurance Engineers to help with the creation and auditing of risk management files, design history files and QMS systems.

You will be based on site in Cambridge with travel to sites across Europe. Although you will mainly be in Cambridge you will need to be able to travel for a week at a time when needed.

As you will be managing the quality assurance of medical devices creation you will need to have a strong understanding of ISO 13485 and FDA 21 CFR Parts 820. It would also be useful to have exposure to EN 60601 and ISO 14971.

This is a large expansion and therefore we are looking for at least three people, however we expect there to be another couple of roles over the next six months. You will work closely with the design groups of the business, so if you have specific design assurance knowledge this will be ideal.

The company, you will be joining, have been growing for a few years and the expansion they are going through has been assured for several years, meaning the job security on offer is unparalleled in the marketplace now.

Communication skills are vital in this role, meaning when you report your finding after an audit you will need to be clear and concise. You will also need to have the confidence to present to a group of junior and senior personnel.

You will be rewarded with an excellent career path, salary, benefits package and pension scheme. So, if you have a strong knowledge as working as a Quality Assurance Engineer, Quality Engineer, Design Assurance Engineer or another quality assurance role please make an application now.

For more information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment specialists Newton Colmore Consulting, on 0121 268 2240 or make an application and one of our team at Newton Colmore Consulting will contact you.

Newton Colmore Consulting is a specialist recruitment company within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors.

Quality Assurance Engineer, Quality Engineer, Medical Devices, ISO 13485, FDA 510k, FDA 21 CFR Parts 820, EN 60601, ISO 14971, Quality Assurance Specialist, Quality Auditor


You must be eligible to work in the UK. Learn more

  • Agency: Newton Colmore
  • Posted: 15th February 2018
  • Expires: 15th March 2018
  • Reference: QAEiC05
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