RadNet · 2 weeks ago
Quality Assurance Specialist
Somerville, MA
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expRadNet is focused on supporting DeepHealth products and product development. The Quality Assurance Specialist will collaborate cross-functionally to guide product development and support Quality Management System processes throughout the organization.
Health CareHealth DiagnosticsHospitalMedical
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 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
Company
RadNet
RadNet provides diagnostic imaging services through a network of 400 owned and operated outpatient imaging centers.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$1.71BKey Investors
Barclays
2025-06-11Post Ipo Debt· $100M
2024-04-11Post Ipo Debt· $1.16B
2024-03-07Post Ipo Equity· $230.2M
Leadership Team
Norman Hames
President & CEO, Western Operations
Stephen Forthuber
President & CEO - Eastern Operations
Recent News
2026-01-08
2026-01-08
2026-01-07
Company data provided by crunchbase