Full-Time Sr. Quality Management System (QMS) Specialist

Company Description:HOPPR is pioneering the next frontier in healthcare technology with the development of a medical-grade platform for the creation and deployment of foundation models in medical imaging. Co-founded by Dr. Khan M. Siddiqui, a renowned leader in healthcare technology and AI, HOPPR is dedicated to improving patient care and outcomes through cutting-edge innovation. Our platform integrates deep learning, AI, and proprietary privacy-compliant trust architecture, setting new standards in healthcare.

Role Overview:We are seeking a detail-oriented and experienced Sr. Quality Management System (QMS) Specialist to ensure compliance with regulatory requirements and industry standards in our growing AI software company. The ideal candidate will manage and maintain the QMS, support audits, and collaborate with cross-functional teams to drive continuous improvement in alignment with ISO 13485, FDA 21 CFR Part 820, IEC 62304, and other applicable regulations.

Key Responsibilities:

1. QMS Maintenance & Compliance:Develop, implement, and maintain the Quality Management System in alignment with ISO 13485, FDA 21 CFR Part 820, IEC 62304, and ISO 14971. Ensure that QMS documentation (procedures, work instructions, policies) remains up to date and aligned with regulatory changes. Manage document control system including document change control, retention policies and system administration responsibilities. Monitor QMS effectiveness and recommend improvements based on industry best practices.
2. Quality Assurance & Audits:Support internal and external audits as needed (external customers, notified bodies, etc.). Prepare audit responses, corrective actions, and CAPA management. Ensure proper document control and record-keeping for regulatory inspections.
3. Post-Market and CAPA Management:Oversee the Corrective and Preventive Actions (CAPA) process, ensuring timely investigation and resolution of quality issues. Track and analyze quality metrics to identify trends and areas for improvement. Oversee post-market monitoring and complaint reporting.
4. Software Development Compliance:Support QA/RA and engineering teams to ensure procedures comply with IEC 62304 (software lifecycle processes). Support documentation efforts for software development, validation, and verification activities. Ensure proper documentation of software outputs and change management processes.
5. Training & Continuous Improvement:Oversee company training system, employee training matrix and assignment of training tasks. Monitor and trend employee training completion and performance. Conduct QMS training for employees, ensuring awareness of regulatory and quality requirements. Promote a culture of quality and continuous improvement within the organization.

Minimum Qualifications:

• Education:Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field.
• Experience:10+ years of experience in quality management for medical devices, with some experience with software as a medical device (SaMD) preferred. Strong understanding of ISO 13485, FDA 21 CFR Part 820, IEC 62304, and ISO 14971.
• Skills:Strong analytical and problem-solving skills. Excellent attention to detail and ability to manage multiple tasks. Effective communication and training skills. Proficiency in QMS software tools.

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