Medical Devices Quality Assurance Specialist

13 hours ago


Aylesbury, Buckinghamshire, United Kingdom Newton Colmore Consulting Ltd Full time
Quality Engineer - Aylesbury - Start-up Medical Devices

We are seeking a highly skilled Quality Engineer to join our growing start-up Medical Devices organisation. Our company is developing a medical device that is revolutionising the lives of thousands of people and has recently gained significant media attention.

As a Quality Engineer, you will report to the Quality Assurance Manager and collaborate with a team of Medical Devices experts, including Mechanical Engineers, Physicists, Electronics Engineers, Software Engineers, and other professionals. Your primary focus will be on Quality Assurance of Medical Devices to ISO 13485 standards, although knowledge of 21 CFR Part 820 or regulatory affairs knowledge would be advantageous.

Key responsibilities will include implementing QMS, validating Medical Devices, managing risk, conducting internal audits, and other duties typical of a Quality Engineer role.

We are open to candidates in Aylesbury and surrounding areas, including Oxford, Swindon, Abingdon, Reading, and other commutable locations. A degree that led to a Medical Devices Quality Engineering career is preferred, but we will consider candidates with alternative routes into the field. A Biotech background is also acceptable, provided you have knowledge of ISO 13485 standards.

This role offers an exciting opportunity to work with a dynamic team and will reward you with a shares/equity scheme, life assurance, pension, private healthcare, income protection insurance, and an employer discount scheme. These benefits are more in line with those of a larger company.

We are considering candidates with varying levels of experience, provided they possess the right attitude. If you are interested, we recommend submitting an application promptly to ensure consideration. Once the company identifies the right candidate, they will extend an offer.

For more information, please feel free to contact Andrew Welsh, Director of Medical Devices, Biotech and Science recruitment specialists, Newton Colmore Consulting Ltd.



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