Director of Quality
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 is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care.
At Biofidelity we are proud to have built a culture of teamwork, openness and trust. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges.
Biofidelity is seeking an experienced and efficient Director of Quality to build and maintain a Quality Management System (QMS) to meet ISO 13485 requirements. Reporting to the Chief Operating Officer, the Director of Quality will be responsible for the Quality Management System and Quality Assurance function across Biofidelity’s US and UK sites.
- Delivering and maintaining a quality management system for ISO 13485 including all subprocesses
- Promote awareness of applicable regulatory requirements, QMS requirements, and customer requirements throughout the organisation
- Developing and delivering training across the company
- Planning, initiating and managing quality improvement projects
- Supporting the product development and software development teams with design control and risk management
- Supporting investigations and complaint handling
- Ensuring supplier and subcontractor compliance to Biofidelity requirements
- Acting as a point of contact with certification authorities, including arranging and planning for assessments
- Assisting with drafting and compilation of product documentation for regulatory submissions
Knowledge, Skills and Abilities:
- Previous implementation and/or maintenance of an ISO 13485 QMS
- Knowledge and demonstrated experience with LDTs and IVDs
- Working knowledge of other applicable standards including 21 CFR 820, 21 CFR Part 11, IEC 62304, ISO 14971, and GAMP5
- Excellent organisational, communication and leadership skills
- Results-oriented, with strong attention to detail
Requisite Education and Experience / Minimum Qualifications:
- Degree in science, medical or technical field
- Proven industry experience in a regulated environment e.g. ISO 13485, ISO 15189, or ISO 17025