Biofidelity’s mission is to improve and extend cancer patients’ lives by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology has been designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care.
We are seeking an experienced and ambitious Quality Manager to build and maintain a Quality Management System (QMS) to meet ISO 13485 and 21 CFR 820 requirements.
Working closely with the senior leadership team, your responsibilities will include:
- Delivering and maintaining document control systems for implementation of ISO 13485
- Developing and delivering training across the company including educating teams on the importance of QMS
- Planning, initiating and managing quality improvement projects
- Acting as a point of contact with accreditation authorities, including arranging and planning for assessments
- Assisting with drafting and compilation of design history files for regulatory submissions
With a strong background in Quality Management, you will have a minimum of 3 years’ industry working in a regulated environment e.g. ISO 13485, ISO 15189, or ISO 17025.
The ideal candidate would have experience in the following areas:
- Previous implementation and/or maintenance of an ISO 13485 QMS
- Working knowledge of other applicable standards including 21 CFR 820, 21 CFR Part 11, IEC 62304, ISO 14971, and GAMP5
- Degree in science, medical or technical field
We offer the chance to join a rapidly growing team working on diagnostic products with the potential for substantial real-world impact, coupled with an excellent working environment, a competitive salary, and a comprehensive benefits package including private medical cover, company share option scheme and 26 days per year holiday allowance.
To apply, please email your CV and cover letter to firstname.lastname@example.org.