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Director of Quality Compliance & Validation Strategy

Lumafield · Boston, MA · On-site

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About Lumafield

The Quality Command Center for Manufacturing. Backed by Kleiner Perkins, IVP and Lux.

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.

What they're looking for

  • An Experienced Quality Professional: 10+ years of experience with a proven track record of managing quality systems in highly technical or regulated environments, particularly in medical devices
  • Compliance Expert: You possess deep, hands-on experience navigating and implementing ISO 9001, ISO 17025, and 21 CFR Part 11, Computer Systems Validation (CSV), and IQ/OQ/PQ
  • Understands the Customer: Able to adapt Lumafield SOPs to satisfy customer requirements in Medical Device, Automotive, Aerospace, and Defense sectors. Understands ISO 13485 & 21 CFR Part 820
  • A Strategic Thinker: You understand how to balance the need for rigorous quality processes with the agility required in a fast-growing startup
  • A Skilled Communicator: You can translate complex quality requirements into actionable guidance for engineers and present system validations with clarity and authority to enterprise customers
  • Collaborative: You enjoy working cross-functionally and view the Quality function as an enabler of speed and innovation
More about this role

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...

Read the full posting on Lumafield's site ↗

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