Quality Manager

Iterative Health is seeking a Quality Manager to lead QMS initiatives for its medical device division. The Quality Manager will ensure compliance with regulations, manage audits, and drive continuous improvement. This role requires strong attention to detail and cross-functional collaboration.

Responsibilities include:

• Ensuring compliance with cGMP, FDA, ISO 13485, and CFR Part 11
• Overseeing the electronic quality management system (eQMS)
• Managing internal and external audits, CAPAs, complaint handling, MDRs, and recall readiness
• Maintaining and improving procedures for configuration management
• Supervising supplier quality, incoming inspection, and calibration activities
• Maintaining quality records including the Device Master Record, labelling files, and training documentation
• Analyzing production and field data to identify trends and drive corrective actions
• Leading continuous improvement initiatives
• Tracking and reporting on quality metrics
• Promoting quality and regulatory awareness through training

Requirements include:

• Experience in a Quality role within a medical device (SaMD preferred)
• Proficiency with electronic quality management systems (eQMS)
• Strong understanding of ISO 13485, ISO 9001, QSR, and cGMP regulations
• Working knowledge of Quality System Regulations and global compliance standards
• Exposure to quality practices in a supply chain or manufacturing context
• Experience supporting regulatory audits and inspections
• Strong interpersonal and influencing skills
• Detail-oriented with a proactive approach to problem-solving
• Solid computer literacy, including Microsoft Office application
• Ability to work effectively in a regulated, fast-paced environment
• A bachelor’s degree with a minimum of 5 years of experience in the field (or lesser degree with more experience)

Iterative Health offers:

• Vision/Dental/ Medical Insurance
• Life/Disability Insurance
• Parental Leave
• Stock Options
• Flexible Work Hours
• Unlimited Paid Time Off