comind - Director of Quality Assurance

• Team Leadership: Lead and develop our existing Quality team, instilling and maintaining a high performance culture. • Ensure the CoMind QMS complies with the FDA QMSR (21 CFR Part 820, harmonised with ISO 13485) and 21 CFR Part 11 for electronic records and signatures, while remaining customer focused and aligned with business needs. • Audit Leadership: Lead our annual ISO 13485 certification audit, FDA inspection readiness and own the internal, supplier, and customer audit programmes. • Design Quality Assurance: Oversee design controls and design transfer to manufacturing including the DHFs and DHRs, ISO 14971 risk management, IEC 62366 useability, UDI requirement, and quality assurance across an integrated product spanning electronics, optics, and software. • Provide oversight and guidance on software development processes including IEC 62304 software development processes, Software as Medical Device (SaMD) classification, and FDA's SaMD/AI-ML guidance. • Cybersecurity: Provide oversight and guidance on cybersecurity aspects impacting product and business processes, including FDA's premarket cybersecurity guidance (Section 524B) • Supplier & Manufacturing Quality: Lead supplier qualification, supplier audits, and manufacturing quality as we build toward commercial production. Work with suppliers to ensure effective Quality Assurance and Quality Control processes are implemented. Establish processes for maintaining Device Master Records, and transfer of batch records to CoMind. • Post-Market Quality: Create the post-market side of the QMS from the ground up as we launch, including complaint handling, product analytics, and on-market quality processes • Work with the RA function to compile Periodic Safety Update Reports (PSUR), vigilance reporting / MDR reporting, or field corrective actions/recalls in line with EU MDR/FDA obligations. • Provide oversight and guidance on clinical evaluation / clinical data quality.