DeepHealth · 2 months ago
Sr. Quality Assurance Specialist
boston, Massachusetts, United States
Full-time
Onsite
Senior Level, Lead/Staff
$98K/yr - $120K/yr
10+ years expDeepHealth is a company focused on product development and compliance. The Sr. Quality Assurance Specialist will support product development and the Quality Management System, collaborating with various teams to ensure compliance and efficiency in quality processes.
Machine LearningMedicalSoftware
Responsibilities
Actively engage cross-functionally within the organization, such as with the Engineering, Clinical and Marketing teams, to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes
Act as the Quality lead for design changes to existing DeepHealth products, including non-medical devices, to ensure compliance with the applicable standards and guidances
Guide junior Quality Assurance team members to ensure consistent implementation of Quality processes, including design control and risk management
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
Participate in the development of junior staff, as requested
Collect/monitor quality metrics in support of Management Review
Qualification
Required
Bachelor's degree in relevant field (or equivalent experience, i.e. Associate's degree with 5 years of experience)
Minimum of 10 years working in a regulated industry (FDA and Software as a Medical Device preferred)
Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820
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
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