Quality Management System Director

Job Summary

As the Head of Product Quality, this remote position will build, scale, and maintain the Quality Management System (QMS) while serving as the primary quality authority for medical device launches, ensuring compliance with ISO standards and overseeing cross-functional alignment across Engineering, Operations, and Regulatory Affairs.

Key responsibilities

• Own and continuously improve the QMS structured around ISO 13485 and ISO 9001 principles
• Review and approve test plans and reports for new product development, ensuring quality requirements are integrated early in the design process
• Manage the risk management process in alignment with ISO 14971, ensuring all risk files are updated throughout the product lifecycle

Required qualifications

• 10+ years of experience in quality engineering or quality systems in a regulated hardware environment
• Hands-on experience with ISO 13485 and/or 21 CFR 820 quality management systems
• Proven ability to review and approve test plans, test reports, and V&V documentation
• Practical experience with CAPA, nonconformance, supplier quality, and internal audit programs
• Bachelor's degree in engineering, a physical science, or a related technical field