Quality Assurance Engineer for Medical Devices
7 days ago
We are a world-leading team of experts developing cutting-edge technological solutions to address humanity's greatest healthcare challenges. Our vision is to make a real difference in people's lives by creating accessible, non-contact, mobile diagnostic health devices.
SalaryWe offer a competitive salary of £55,000 - £65,000 per annum, depending on experience, plus benefits.
Job DescriptionWe are seeking a highly skilled Device Compliance and Regulatory Expert to join our Quality Management System (QMS) team in Reading. As a key member of our team, you will be responsible for ensuring the quality and safety of our medical devices, from design to launch.
Your primary duties will include:
- Regulatory Compliance: Ensure compliance with regulatory requirements such as ISO 13485, EU MDR 2017/745 & 21CFR820, through effective risk management and quality activities.
- Design and Development: Support the generation and review of design history files, including verification and validation activities for R&D prototypes.
- Quality Assurance: Conduct internal and external audits, provide regulatory and quality education and training, and support the assessment of external suppliers.
As a Device Compliance and Regulatory Expert, you will work closely with cross-functional teams to ensure the quality and safety of our products. You will be responsible for reviewing and approving project-related documentation, generating regulatory submission data, and providing input into verification and validation activities.
This is a challenging and rewarding opportunity for a highly motivated individual who is passionate about improving people's health around the world. If you have a strong understanding of regulatory requirements, excellent communication skills, and experience in coding software (e.g. MATLAB, C++, Arduino), we encourage you to apply.
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