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Quality Manager - QMS ISO 13485 - Letchworth Garden City

Hertfordshire   •  Negotiable  •  Permanent, Full time


Quality Manager - QMS ISO 13485 - Letchworth Garden City and Homebased

Due to expansion plans of a Medical Devices company based around Letchworth Garden City, Hertfordshire, we are looking for an experienced Quality Manager who will be able to establish a QMS from scratch, specifically to ISO 13485 standards.

You will also be creating and managing technical files for a number of Medical Devices lines for Class I, Class IIa and Class IIb Medical Devices. This is a unique role that will allow you to split your role from being in the office and working from home, however this split will need to be agreed between yourself and the company to make sure you still have the support you need to be successful.

This is not a Quality Manager role where you will be leading a team, you will be providing all of the Quality Assurance duties yourself. As the company grows there may be new roles that will report into you, but this is not going to happen quickly. So, if you are not happy working on the quality duties yourself, this is not the role for you.

Apart from having a Quality Assurance, to ISO 13485 standards, background it would also be highly advantageous if you have a good understanding of Regulatory Affairs too.

Part of your role will be 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, however this is not essential.

You will be rewarded with an excellent starting salary, end of year bonuses, health insurance and other benefits.

I expect a lot of interest in this role and expect the organisation to move quickly with their hire, so if you are interested in this role I suggest you make an application now or risk missing out.

For more information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment and Scientific recruitment specialists Newton Colmore Consulting, on +44 121 268 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, Data Science, Machine Learning, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors.


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

  • Agency: Newton Colmore Consulting
  • Reference: QMqiLGCaH01
  • Posted: 6th November 2020
  • Expires: 4th December 2020

Newton Colmore Consulting

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