Quality and Regulatory Engineer

1 month ago


Clevedon Somerset, United Kingdom Cure Talent Ltd Full time

Cure Talent are excited to be working with a growing Medical Technology Start-Up, specialising in Wearable Technology. Due to their exceptional continued growth, we have a superb opportunity for a Quality Engineer to join the team.
As the new Quality Engineer, you will ensure product safety, reliability and regulatory compliance through meticulous hardware and software verification testing. You will be responsible for the creation of regulatory documentation, maintenance of QMS processes and the identification of opportunities for Continuous improvement.
To be successful as the new Quality Engineer we are looking for an experienced Quality professional with proven experience in the verification testing of Medical Devices (both Hardware and Software).
Develop and execute verification test plans for both hardware and software components, conducting testing to adhere to design specifications and regulatory requirements.
Prepare and maintain regulatory documentation, including test protocols.
Implementation and management of QMS processes to aid in the full development lifecycle.
Review of project documentation to ensure compliance with Quality Standards.
Degree educated in an Engineering or Scientific field (highly advantageous)
Proven experience in a Quality Engineering role in Medical Devices
Demonstrable knowledge and experience in the verification testing of Medical Devices.
Experience with Risk Management, PMS, Change Controls



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