Quality Management System Manager

InsightRX is seeking an experienced QMS Manager to support the rapid growth of their healthcare technology platform. The ideal candidate should have knowledge of software as medical device development and clinical trials, specifically GxP, CFR Part 11, and EU CE Mark (ISO 13485, IEC 62304) requirements. As the QMS Manager, you will be responsible for managing the development, implementation, and maintenance of the company's QMS procedures, as well as coordinating audit responses. This role requires close collaboration with engineers, product managers, regulatory teams, and management in an agile environment.

• Manage the development, implementation, and maintenance of the Quality Management System (QMS) procedures
• Ensure compliance with GxP, CFR Part 11, and EU CE Mark (ISO 13485, IEC 62304) requirements
• Coordinate audit responses
• Work closely with engineers, product managers, regulatory, and management
• Operate in a collaborative and agile environment

• Experienced QMS manager
• Knowledge of software as medical device development and clinical trials (GxP, CFR Part 11)
• Ability to manage the development, implementation, and maintenance of QMS procedures
• Familiarity with GxP, CFR Part 11, and EU CE Mark (ISO 13485, IEC 62304) requirements
• Coordination of audit responses
• Collaboration with engineers, product managers, regulatory, and management in an agile environment

• Medical, Dental, Vision, Life Insurance, and Long-Term Disability
• 401(k)
• Unlimited PTO
• Remote Opportunities
• Professional Development
• Stock options