Director of Regulatory Compliance & Validation Strategy
Job Description
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.
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.