DeepHealth · 8 hours ago
Quality Assurance Specialist
Somerville, Massachusetts, United States
Full-time
Onsite
Mid, Senior Level
5+ years expDeepHealth is a company focused on healthcare technology, and they are seeking a Quality Assurance Specialist to support their products and development processes. The role involves collaborating cross-functionally to ensure compliance with quality management systems and drive efficiency in product development.
Machine LearningMedicalSoftware
Responsibilities
Work cross-functionally with the Engineering, Clinical and Marketing teams to develop new products and implement design changes to existing DeepHealth products
Take ownership of product specific Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency
Work cross-functionally to integrate products as a result of corporate and/or product acquisitions
Work as a team member with the Quality Assurance team to ensure compliance to US and OUS standards and regulations
Qualification
Required
Bachelor's degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience)
Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820
5 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred)
Excellent written and oral communication skills
Preferred
Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304
Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56
Participation in regulatory audits a plus
Company
DeepHealth
DeepHealth uses machine learning to distill lifetimes of insights from medical experts into software to assist radiologists.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$0.22MKey Investors
National Science Foundation
2020-03-11Acquired
2019-08-29Grant· $0.22M
Leadership Team
Greg Sorensen
CEO and Co-founder
Bryan Haslam
Chief Product Officer
Recent News
2025-12-02
2025-12-01
Company data provided by crunchbase