Bionano is looking for a proven quality player coach to join Bionano’s senior leadership, reporting directly to the Chief Operating Officer, with responsibility for driving Bionano’s quality assurance and compliance strategies. This person will be hands on in executing the Quality Management System (QMS) that relies on OEM partners for ISO 13485 compliance. This role ensures robust supplier management, document control, CAPA management, and compliance with the EU’s IVDR and other global regulatory requirements. The ideal candidate will have experience in executing and managing quality for outsourced manufacturing environments and driving continuous improvement across the supply chain. This person will have minimal direct staff and will work through other Bionano organizations, OEM partners and outsourced staff. This is a full-time position located in our San Diego headquarters, with key suppliers and distribution centers located globally.