Aignostics

Manager

• Build Robust Quality Systems: Establish and maintain CAPA management systems in full compliance with ISO 13485
• Design and oversee change management processes aligned with ISO 13485 and IEC 62304
• Maintain comprehensive QM documentation including SOPs, work instructions, and quality records
• Translate regulatory requirements (IVDR, ISO 13485, FDA QSR) into actionable QM system elements
• Analyze quality and change data to identify trends, systemic issues, and improvement opportunities
• Enable Cross-Functional Excellence: Partner with software engineers, data scientists, and product teams on root cause analysis and corrective measures
• Coordinate and support internal and external audits (notified body, regulatory authorities)
• Facilitate CAPA and change review meetings where diverse perspectives are heard and the best ideas win
• Build collaborative relationships across all departments to embed quality thinking everywhere
• Foster a Learning Culture: Develop and deliver training programs on CAPA management, change control, and quality processes
• Share lessons learned from CAPAs and audits to drive organizational learning
• Create a psychologically safe environment where quality concerns can be raised openly
• Mentor team members and stakeholders in quality management principles

Quality Manager Specialist – CAPA, Change Management

Backend Engineer

• Build and scale data infrastructure for our digital pathology platform
• Design services and APIs that enable high-throughput access to medical image data for machine learning
• Lead technical initiatives, and drive improvements to our SaaS product
• Work closely with frontend and ML teams to deliver solutions that power biomedical analyses

Quality Manager Specialist – CAPA, Change Management

Senior Backend Engineer – Tech Lead, Data Management