Quality Manager

A BIT ABOUT SIBEL HEALTH With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies—where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we’ve launched our technologies in 20 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations in the world from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and CE Mark approval, we are poised for growth and expansion. We are seeking mission‑driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients. THE OPPORTUNITY We are looking for a Quality Manager to join our team and lead our Quality Assurance function. This role is responsible for driving the continuous evolution of Sibel’s Quality Management System. We are not looking for a compliance gatekeeper - We are looking for someone who views quality as a business transformation tool that accelerates development without sacrificing safety or compliance. The right candidate brings deep medical device QA expertise, proven experience leading and mentoring a QA team, and - critically - demonstrated hands‑on experience deploying transformative AI tools to improve quality operations. This is not about using AI to generate documents. This is about using agentic platforms to fundamentally change how a quality function operates: faster investigations, smarter trend analysis, leaner workflows, and better decisions. WHAT YOU WILL BE WORKING ON Work within a small but mighty QARA team to drive direction setting and provide team mentorship. Lead internal and third‑party audits, including annual planning, execution, auditor hosting, evidence preparation, and timely closure of all findings. Own QMS definition and improvement—translating ISO 13485, EU MDR 2017/745, FDA 21 CFR 820, and MDSAP requirements into clear, scalable, inspection‑ready procedures and records within the document hierarchy. Lead Quality Planning for the establishment and continuous improvement of QMS processes, ensuring they are lean, scalable, and aligned with product lifecycle and business needs. Drive the active deployment of transformative AI tools across QA operations—building and scaling agentic workflows for data trending, document review, investigation support, complaint analysis, and quality reporting, while maintaining appropriate governance, validation, data integrity, and regulatory compliance. Lead the CAPA process end‑to‑end: issue intake, root cause investigation, corrective and preventive action planning, effectiveness verification, and ongoing monitoring for timeliness and quality. Own or directly support complaint handling activities, including review, triage, investigation, trend analysis, and alignment with post‑market surveillance, risk management, and regulatory reporting requirements. Partner with cross‑functional teams to support supplier quality oversight, including supplier qualification, monitoring, audit support, and quality agreement alignment. Develop, maintain, and communicate quality metrics and KPIs across all key QMS process areas: audits, CAPA, complaints, training, document control, supplier quality, and nonconformance management. Perform data‑driven trend analysis and QMS performance evaluation using continuous improvement tools including control charts, Pareto analysis, FMEA, 5‑Why, and process flow mapping. Drive continuous improvement across the QMS by identifying recurring issues, simplifying workflows, reducing waste, and embedding preventive, risk‑based thinking throughout the organization. QUALIFICATIONS Bachelor’s degree in Science, Engineering, or a related field. Minimum 6 years of hands‑on experience across all major quality domains in a medical device company, including CAPA, internal audits, complaint handling, document control, supplier quality, and risk management. ISO 13485 Lead Auditor Certification. Demonstrated hands‑on experience using AI tools, including agentic platforms, to meaningfully improve quality operations. Experience managing or leading a QA team. Deep working knowledge of ISO 13485:2016, ISO 14971, EU MDR 2017/745, and FDA 21 CFR Part 820. Proven ability to thrive in a startup or early‑stage environment: comfortable developing, improving, and working within a quality system simultaneously. PREFERRED MDSAP audit experience. Experience with Arena PLM or similar eQMS/PLM platforms. Familiarity with IEC 62304 software lifecycle or IEC 62366 usability engineering requirements. YOU MAY THRIVE IN THIS ROLE IF You believe quality is a competitive advantage - a function that accelerates development, not one that slows it down. You have moved well beyond using AI as a drafting tool and are actively building and deploying AI‑powered workflows to solve real quality problems. You can operate at both the strategic and tactical level: setting direction for your team while remaining hands‑on when the work demands it. You embrace a lean quality philosophy and take pride in building compliant, efficient, scalable systems in a startup environment. You take full ownership of your function’s outcomes and hold yourself and your team to the highest standards of integrity and accountability. BENEFITS Medical, dental, vision, life, and disability insurance. "Take as much time as you need" policy. Stipend for professional development. Simple IRA plan with employer matching. Company-sponsored events and lunches. Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring. EEO STATEMENT Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. #J-18808-Ljbffr