Director Quality Assurance

Kinomatic; Cleveland, Northern (OH, KY); Hybrid; USD 123,000 - 197,000; Full time

Benefits offered by this job

Hybrid work environment

Equal opportunity employer

Job summary

Kinomatic is seeking a Quality Assurance Director to build and own the QMS for our orthopedic surgical planning SaMD. This leadership role will drive quality across software development, product delivery, and regulatory compliance.

You will lead ISO 13485, IEC 62304, and ISO 14971 activities, establish design controls, risk management, and CAPA, partnering with engineering, product, security, and leadership to embed quality throughout the product lifecycle.

Qualifications

• 8+ years of Quality Assurance and/or Regulatory Affairs experience supporting Software as a Medical Device (SaMD) or medical device software.
• Hands-on experience implementing and maintaining quality processes aligned with ISO 13485, IEC 62304, ISO 14971, and IEC 62366-1.
• Experience building or significantly developing a QMS within a growing organization, including the ability to create practical, scalable processes without relying on an established quality infrastructure.
• Strong understanding of design controls, software lifecycle documentation, risk management, CAPA, complaint handling, change control, internal audits, and post-market quality processes.
• Experience working cross-functionally with software engineering, product development, cybersecurity, clinical, and business teams.
• Experience working with electronic Quality Management Systems (eQMS), such as Greenlight Guru, preferred.

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.

Skills

Quality Assurance

Regulatory Affairs

SaMD experience

Cross-functional collaboration

Auditing

Education

Bachelor's degree in Biomedical Engineering, Engineering, Life Sciences, Quality, Regulatory Affairs, or related field

Tools

Greenlight Guru (eQMS)

Job description

Job DetailsJob Location: CLE Hybrid - Cleveland, OH 44113Position Type: Full TimeSalary Range: $123,040.00 - $196,800.00 SalaryJob Category: QA - Quality Control

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.

QualificationsEducation

Bachelor's degree in Biomedical Engineering, Engineering, Life Sciences, Quality, Regulatory Affairs, or a related field, or equivalent relevant experience.

Required Knowledge, Skills and Abilities

• 8+ years of Quality Assurance and/or Regulatory Affairs experience supporting Software as a Medical Device (SaMD) or medical device software.
• Direct, hands-on experience implementing and maintaining quality processes aligned with ISO 13485, IEC 62304, ISO 14971, and IEC 62366-1.
• Experience building or significantly developing a QMS within a growing organization, including the ability to create practical, scalable processes without relying on an established quality infrastructure.
• Strong understanding of design controls, software lifecycle documentation, risk management, CAPA, complaint handling, change control, internal audits, and post-market quality processes.
• Experience working cross-functionally with software engineering, product development, cybersecurity, clinical, and business teams.
• Experience working with electronic Quality Management Systems (eQMS), such as Greenlight Guru, preferred.

Salary $123,040 - $196,800

Kinomatic is transforming orthopedic surgery through proprietary 3D visualization and VR technology that enables surgeons to rehearse procedures before entering the operating room. As we expand our direct-to-patient presence, we are building the scalable growth engine that powers awareness, education, and long-term advocacy.

Kinomatic is an equal opportunity employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.