Quality Manager/ Sr. Manager – Cloud-Based Medical Devices

Company: AngioInsight Inc.

Location: Minnetonka, MN (Hybrid)

Job Type: Full-Time

Department: Quality Assurance

Reports To: Sr. Vice President of Regulatory Affairs & Quality

At AngioInsight, we are pioneering AI-driven cardiovascular imaging technology that leverages cloud-based medical device solutions to enhance patient care. Our platform provides real-time insights to physicians, enabling faster diagnosis and better clinical outcomes.

As we continue to grow, we are seeking a Quality Manager or Sr. Quality Manager to continue to establish and oversee our Quality Management System (QMS), compliance processes, and validation activities for our Software as a Medical Device (SaMD) platform.

This is a foundational hire, providing an opportunity to build and help lead quality assurance for novel cloud-based medical devices at AngioInsight.

The Quality Manager will be responsible for developing, maintaining and improving software quality design processes, ensuring compliance with ISO 13485, FDA QSR (21 CFR Part 820), ISO 14971 and applicable SaMD regulations and guidance. This role involves supporting development of deliverables for regulatory market submissions, software verification and validation, regulatory audit readiness, supplier quality oversight, and cross-functional collaboration with research, DevOps engineering, clinical and regulatory teams.

·     Establish and maintain a QMS (Quality Management System) for cloud-based medical devices in compliance with ISO 13485, FDA QSR (21 CFR Part 820), and cGMP.

·     Develop and oversee SOPs, work instructions, and training programs for cloud-based product development.

·     Ensure compliance with SaMD (Software as a Medical Device) regulatory guidelines, external standards and oversee software validation and verification (V&V).

·     Prepare for ISO 13485 certification, lead FDA audits, and supplier audits.

·     Collect, analyze and track quality metrics to monitor QMS, device performance and provide recommendations for improvement. Generate reports and recommendations for Management Reviews.

·     Implement risk management practices aligned with ISO 14971, regulatory guidance and post-market surveillance procedures.

·     Work with engineering, DevOps, and regulatory teams to ensure quality integration in software development and promote safety, reliability and compliance of AngioInsight technologies.

·     Oversee CAPA (Corrective and Preventive Actions), non-conformance reports, and continuous process improvements.

·     Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies

·     5 years of experience in quality assurance or regulatory compliance for medical devices with focus on SaMD products.

·     Strong knowledge of all aspects of the QMS related to design controls, product development lifecycle, ISO 13485, FDA QSR (21 CFR Part 820), cybersecurity, usability and risk management (ISO 14971) for software based products.

·     Experience leading development projects maintaining design controls and risk management compliance from early design and development through commercialization

·     Experience with cloud-based software validation, supplier quality management, CAPA and audit preparation.

·     Proficiency in using tools for documentation, defect tracking, investigation and test management (e.g., Jira, git).

·     Ability to lead audits and manage regulatory inspections for medical device compliance.

·     Minimum of a Bachelor’s degree in quality, Computer Science, Engineering or related Scientific discipline

·     Exceptional collaboration, problem-solving, critical-thinking, and decision-making skills.

·     Experience with ISO 27001 and GDPR compliance and EU Medical Device Regulations for software products

·     Familiarity with 510(k) submissions and regulatory documentation for SaMD devices.

·     Certification such as Certified Quality Engineer (CQE) or Lead Auditor for ISO 13485.

·     Experience with Machine Learning AI/ML health technologies, GMLP