Director of Quality Compliance & Validation Strategy at Lumafield in Boston, MA

Job description

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. What you'll do: Own the QMS: Design, implement, and maintain a unified QMS that covers the full scope of Lumafield’s operations, ensuring scalability and adherence to international quality standards. Lead Compliance Initiatives: Lead Lumafield’s compliance program against ISO 9001 (general QMS) and ISO/IEC 17025 (metrology and calibration), and prepare the company for additional certifications as the business expands. Customer Validation: Work directly with enterprise customers to demonstrate the robustness of Lumafield’s systems, providing technical documentation and assurance for their validation processes. Deliver approach for a validated solution : Advise on and provide leadership to Product and Engineering for Lumafield to provide fully validated solutions to our customers in regulated industries Manage External & Internal Audits: Serve as the primary point of contact for customer audits, regulatory body inspections, and internal quality assessments. Act as a Strategic Advisor: Partner with engineering, product, customer success, and sales teams to provide guidance on regulatory requirements and quality assurance best practices. This includes directly working with customers who need to validate Lumafield’s systems inside their own QMS and submissions. Drive Continuous Improvement: Cultivate a culture of continuous improvement across the organization, using data-driven insights to refine processes and mitigate risks. About you: An Experienced Quality P