Director of Regulatory Compliance & Validation Strategy

About Lumafield:    Lumafield was founded in 2019 to upgrade manufacturing.   We are engineers with deep experience across the product development cycle, from initial ideas to shipping hardware, across industries and specializations, who became frustrated by the cost and complexity of modern manufacturing. So we decided to upgrade it.   Engineers make million-dollar decisions every day, and they need tools that give them the greatest possible insight into their products. By offering unprecedented visibility into products, as well as AI-driven tools that highlight problems and generate quantitative data, Lumafield promises to revolutionize the way complex products are created, manufactured, and used across industries. We started with industrial CT scanning, which for us was the most valuable but underutilized tool in the manufacturing toolbox, enabling us to rapidly inspect essential components non-destructively.   We rebuilt the whole system, from X-ray capture, to computer vision analysis, to web-based collaboration, to the entire business model, making the most advanced manufacturing tech more accessible to every industry. Our company, like our platform, is designed for upgrades. We’re building for greater intelligence, autonomy, and speed. For deeper vision, operational excellence, and powerful insights. And then we'll upgrade it all again.   Lumafield is headquartered in San Francisco, CA. and has an office in Cambridge, MA.  About the role:  Quality is how Lumafield earns trust — with the engineers who rely on our scanners to make million-dollar decisions, with the regulated industries we serve, and with the certification bodies who audit us.  Lumafield’s Quality Leader will own the Quality Management System across all of Lumafield: design and development planning, hardware manufacturing, software, cloud services, metrology and measurement, field service, and our customer-facing applications engineering and scan lab operations. The Quality Leader acts as a bridge between our cutting-edge technology and the rigorous compliance standards our customers demand. This can include leading our efforts in achieving and maintaining compliance with ISO 9001, ISO 13485, ISO 17025, 21 CFR Part 820, and potentially IATF 16949 and AS9100, however the primary industry focus is medical devices.  You will act as a strategic advisor to our internal teams, spanning sales, customer success, product and engineering. You’ll also guide customers and support validation of our systems and lead customer audits.