Quality Officer Quality and Regulatory Main Office Hybrid Remote

Quality Officer - London, UK (Hybrid/Office Based/Remote)

Annual Salary: £32-£37k

Odin Vision, an Olympus company, is a multi-award winning company that provides state of the art AI enabled software applications for endoscopic procedures to aid clinicians in the detection and diagnosis of disease, supporting higher quality care, improved patient outcome and better value for healthcare payers.

The Quality Officer role is a full time position and will be part of the QARA Team. You will be part of a team that is focused on ensuring Quality standards are met so that we can place products on the market.

We are looking for an individual who is motivated, willing to learn, has an eye for detail and can work well within a team or on their own.

What you'll do:

• Support and maintain a quality management system to support CE and FDA regulatory approvals for the Company's software products, this includes, but is not limited to, interacting with auditors, notified bodies, end users, patients and external consultants;
• Collect and manage data, supporting requirements analysis and documentation, end user testing, verification and validation;
• Log any non-conformities raised on the system and support relevant stakeholders;
• Work with the line managers to ensure all employees are trained and competent, this will include updating training records and material;
• Support with design changes;
• Maintain an electronic QMS (e.g. Cognidox) in an organized and searchable way;
• Collect and present KPI data on the performance of the QMS and other company objectives;
• Work with teams to improve, automate and streamline Quality Processes;
• Manage the various aspects of document control within the QMS;
• Support and participate in risk management activities;
• Reporting and communication between Odin Vision and Olympus;
• Deputise for the Quality Manager in their absence.

Qualifications

• Desirable, but not required: Internal Auditor Qualification;
• Undergraduate bachelor's degree.

Experience

• Experience with ISO 13485 or similar Quality Management System standard (ISO 9001);
• Experience with EU MDR;
• Experience with Software as a Medical Device;
• Experience using GenAI tools such as ChatGPT.

At Odin Vision we believe that diversity is an important contributor to our success and long-term company goals. Diversity in our teams can contribute to innovations and creativity and increase our ability to cope with change. Odin Vision is committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our workforce to be truly representative of all sections of society and our customers, and for each employee to feel respected and able to give their best.