Director Quality Assurance

The Opportunity

Kinomatic is seeking a Quality Assurance Director to build, implement, and own the Quality Management System (QMS) supporting our orthopedic surgical planning software (SaMD).

This is a foundational role responsible for establishing scalable quality processes from the ground up, ensuring our software development and product delivery practices are auditable, compliant, and aligned with applicable FDA regulations and industry standards. The ideal candidate brings deep SaMD quality experience, a hands-on approach to building systems, and the ability to partner across engineering, product development, security, and leadership to embed quality throughout the product lifecycle.

Responsibilities

• Build, implement, and maintain Kinomatic’s Quality Management System, including the Quality Manual, quality policy, objectives, document control, record control, management reviews, training requirements, and quality metrics aligned with ISO 13485 and applicable FDA Quality Management System Regulation requirements.

• Partner with Product Development and Software Engineering to establish and maintain design controls, including design planning, inputs, outputs, verification, validation, transfer, Design and Development Files, and end-to-end requirements traceability.

• Establish quality processes supporting an IEC 62304-aligned software development lifecycle, including software safety classification, configuration management, controlled builds, environment management, and release approval requirements.

• Lead ISO 14971 risk management activities throughout the product lifecycle, including hazard analysis, clinical risk evaluation, risk controls, residual risk assessment, and risk-benefit documentation across both the software and surgical planning workflow.

• Implement usability engineering processes aligned with IEC 62366-1 and support formative and summative usability studies with representative surgical users.

• Partner with Engineering and Security to establish quality controls supporting cybersecurity, secure software development, threat modeling, Software Bill of Materials (SBOM) generation, patient imaging data integrity, and PHI handling.

• Establish supplier qualification, purchasing controls, and ongoing monitoring processes for third-party software libraries, imaging facilities, cloud infrastructure providers, contract development partners, and other critical suppliers.

• Own software release quality controls, nonconforming product processes, change control, complaint handling, adverse event evaluation, post-market surveillance, and Corrective and Preventive Action (CAPA) processes.

• Plan and execute internal quality audits and drive continuous improvement based on audit findings, CAPAs, management review outcomes, product performance, and post-market data.

• Provide regulatory strategy support related to device classification, technical documentation, FDA submissions, and applicable regulatory requirements.