Quality Assurance Engineer - Medical Device (MDR ISO 13485)
Location: Leeds
Salary: Up to £50,000
Are you a passionate and detail-oriented Quality Assurance professional with an interest in working on a complex medical device? We are seeking a dedicated Quality Assurance Engineer to become the expert in ensuring the highest standards in the development and manufacturing of medical devices. This role offers the opportunity to contribute to the success of an exciting and cutting-edge medical device while receiving training to thrive in the position.
Key Responsibilities:
Oversee the implementation and adherence to MDR (Medical Device Regulation) and ISO 13485 in the development of medical devices.
Ensure all quality assurance processes align with the latest medical regulation requirements, focusing on MDR compliance.
Create and manage standard operating procedures (SOPs), documentation, and reports in line with 13485 standards.
Conduct regular audits, inspections, and testing of medical devices to ensure they meet both MDR and ISO 13485 requirements.
Support the creation and maintenance of documentation related to regulatory submissions and quality systems for medical devices.
Provide expertise on medical regulation and offer guidance for continuous improvement of the medical device lifecycle.Essential Requirements:
Experience in Quality Assurance for medical devices, ideally with knowledge of MDR and ISO 13485.
Familiarity with medical regulation ...