Quality Assurance VP

Job Summary

Quality Assurance VP, responsible for leading the ISO 13485 certification process, designing and integrating quality management systems, and building a high-performing quality team in a full-time remote position.

Key Responsibilities

• Own the ISO 13485 certification roadmap and manage core quality management system processes
• Partner with engineering to configure quality management systems within the product lifecycle management platform
• Act as the primary liaison for customer quality issues and drive corrective actions

Required Qualifications

• 10+ years of quality experience in medical devices with leadership responsibility
• Multiple ISO 13485 certifications personally led or co-led
• Hands-on experience building a quality management system within a PLM environment
• Working knowledge of 21 CFR Part 820, ISO 14971, and IEC 62304
• Experience in hardware/systems quality, software quality, and supply chain quality