Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Iterative Health is seeking a Quality Manager. This dynamic, fast-paced role will 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/software engineers, 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 cGMP, FDA, ISO 13485, 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
- 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 engagement
Required 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, 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 environment
Education and Experience Requirements
- A bachelor’s degree with a minimum of 5 years of experience in the field
- Lesser degree with more experience considered
Some 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 [email protected].
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What We Do
At Iterative Health, we are a pioneer in the application of artificial intelligence-based precision medicine to gastroenterology with the aim of establishing a new standard of care for the detection, and ultimately, treatment of gastrointestinal (GI) diseases. Our powerful, proprietary artificial intelligence and computer vision technologies are designed with the goal of improving the accuracy and consistency of endoscopy readings.
We believe the work underway at Iterative Health will lead to better patient care, allowing people suffering from IBD – and, eventually, other GI diseases – to improve their quality of life, relationships with their doctors, and access to clinical trials and potential therapeutic advances. And we're a group of dedicated, passionate people who find energy in working together to address these big challenges. We're headquartered in Cambridge, not far from MIT, where we were founded in 2017
Why Work With Us
At Iterative Health, we strive to do high quality work, create supportive, open, and friendly work environments infused with a diversity in background, perspectives, and approaches, and form high performing teams that encourage collaboration, empathy, and open communication. We believe great teams will help us transform gastroenterology.
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