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NEXTMOVEFDE careers · United States
Lumafield

Director of Quality Compliance & Validation Strategy

AI summary of the role

Lumafield seeks a Director of Quality Compliance & Validation Strategy to own the entire Quality Management System across hardware, software, cloud, metrology, and field service, with a primary focus on medical devices.

What you’ll do

  • Own the QMS: Design, implement, and maintain a unified QMS covering all Lumafield operations, ensuring scalability and adherence to international quality standards.
  • Lead compliance initiatives against ISO 9001 and ISO/IEC 17025, preparing for additional certifications as the business expands.
  • Work directly with enterprise customers to demonstrate system robustness and provide technical documentation for their validation processes.
  • Serve as primary point of contact for customer audits, regulatory inspections, and internal quality assessments.

What you’ll bring

  • 10+ years of experience managing quality systems in highly technical or regulated environments, particularly medical devices.
  • Deep hands-on experience with ISO 9001, ISO 17025, 21 CFR Part 11, Computer Systems Validation (CSV), and IQ/OQ/PQ.
  • Ability to adapt SOPs to satisfy customer requirements in Medical Device, Automotive, Aerospace, and Defense sectors; understanding of ISO 13485 & 21 CFR Part 820.
  • Strategic thinker who balances rigorous quality processes with startup agility.

Technologies

ISO 9001 · ISO 13485 · ISO/IEC 17025 · 21 CFR Part 820 · 21 CFR Part 11 · CSV · IQ/OQ/PQ · CAPA · MSA · GD&T

About Lumafield

Accessible industrial X-ray CT scanners and cloud software for engineers inspecting complex physical products from R&D through production.

Series C · 100–200 people

Source and classification

Deployment strategy · Evidence for this classification:

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
How jobs are selected

Employer postings · Data from · Sources