Senior Quality Assurance Specialist

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November 7

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DeepHealth

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Artificial Intelligence • Healthcare Insurance • SaaS

DeepHealth is a global leader in AI-powered health informatics, providing innovative solutions designed to enhance operational efficiency and clinical confidence in radiology. As a wholly-owned subsidiary of RadNet, Inc. , DeepHealth offers a comprehensive suite of diagnostic and imaging tools, including the DeepHealth OS, a pioneering cloud-native operating system. Their AI-powered solutions support large-scale diagnostic programs and streamline workflows in areas such as breast, prostate, lung, and brain cancer detection. DeepHealth collaborates with leading healthcare institutions worldwide to transform radiology practices and improve care delivery.

11 - 50 employees

🤖 Artificial Intelligence

⚕️ Healthcare Insurance

☁️ SaaS

💰 $225k Grant on 2019-08

📋 Description

• 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.

🎯 Requirements

• 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. • Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred. • 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, preferred but not required. • Participation in regulatory audits a plus. • Excellent written and oral communication skills.