Position: Software Quality Analyst
Category: Business Analyst
English level: fluent
Years of experience: 6


Overall, ten years of experience in quality and process management in various industries
(medical industry, automotive).
Five years of experience in Computer-Assisted Surgical Systems Software Verification and
Validation.
Establishing software verification and validation process to comply with regulatory and
standards' requirements (ISO 9001, ISO 13485, IEC 62304, FDA CFR, EU MDR, ASPICE,
ISO27001/27002);
Plan and conduct product risk analysis (ISO 14971);
Perform internal audits and support teams during external audits;
Analysis of process and product nonconformity, arise and process CAPA (root cause
analysis, action plan development, track plan implementation, effectiveness analysis);
Writing process documentation, product requirements, test documentation;
Creation training materials and providing training;