Iterative Health is a healthcare technology and services company on a mission to advance gastrointestinal care through relentless innovation. With deep expertise in artificial intelligence and clinical research, we empower healthcare professionals to provide consistently high-quality colorectal cancer screenings and support clinical research teams and study sponsors to expand and accelerate patient access to novel therapeutics.
Iterative Health is seeking a Quality Manager. This dynamic, fast-paced rolewill require experience with leading QMS initiatives to support the medical device side of Iterative health and is required to have strong attention to detail and documentation. A successful candidate will work cross-functionally with a diverse team of machine learning and hardware/softwareengineers, clinical experts, and product managers to solve challenging real-world scientific problems that have a company-wide impact.
The person in this role will be responsible for the day to day activities associated with the management all quality department initiatives. Candidates must have a strong knowledge of the applicable medical device regulations.Quality Manager Job Responsibilities:●Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971 and CFR Part 11 across all quality processes and documentation●Oversee the electronic quality management system (eQMS), ensuring full utilization and regulatory alignment●Manage internal and external audits, CAPAs, complaint handling, MDRs, and recall readiness●Serve as QMS subject matter expert (SME) and primary liaison for internal audits, regulatory inspections, and third-party audits.●Maintain and improve procedures for configuration management, including change control, validation, and rollout planning●Supervise supplier quality, incoming inspection, and calibration activities, ensuring accurate records and effective controls●Maintain quality records including the Device Master Record, labelling files, and training documentation●Analyze production and field data to identify trends, drive corrective actions, and support continuous improvement●Lead continuous improvement initiatives to reduce defects and enhance product quality and process consistency●Track and report on quality metrics, audit outcomes, and customer feedback to inform quality initiatives●Promote quality and regulatory awareness through training and cross-functional engagementRequired Skills:●Experience in a Quality role within a medical device, experience with SaMD preferred●Proficiency with electronic quality management systems (eQMS)●Strong understanding of ISO 13485, ISO 9001, IEC 62304, 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 across functions●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 environmentEducation and Experience Requirements●A bachelor’s degree with a minimum of 5 years of experience in the field●Lesser degree with more experience consideredSome of our benefits include:
- Vision/Dental/ Medical Insurance
- Life/Disability Insurance
- Parental Leave
- Stock Options
- Flexible Work Hours
- Unlimited Paid Time Off
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
