Lumafield

Director of Regulatory Compliance & Validation Strategy

Boston, MA · Director

Sponsorship not specified$160k-$190kDetected 42 days ago

Computer VisionComplianceCustomer SuccessGD&TFDA RegulatoryMedical DevicesLeadershipCollaboration

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.
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.

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.
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.
Drive Continuous Improvement: Cultivate a culture of continuous improvement across the organization, using data-driven insights to refine processes and mitigate risks.
Our company, like our platform, is designed for upgrades.
We're building for greater intelligence, autonomy, and speed.

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
A Strategic Thinker: You understand how to balance the need for rigorous quality processes with the agility required in a fast-growing startup.
Collaborative: You enjoy working cross-functionally and view the Quality function as an enabler of speed and innovation
You understand how to balance the need for rigorous quality processes with the agility required in a fast-growing startup.

Experience with FDA 21 CFR Part 820, EU MDR, IATF 16949, AS9100, or NADCAP.
Prior experience standing up a calibration lab or ISO/IEC 17025 scope from scratch.
Experience with statistical process control, test method validation/MSA, CAPA, NCMR, PPAP, FAI.
Experience at a fast-growing hardware/software company where the QMS had to scale with the business

Lumafield offers both competitive cash and equity compensation, as well as a health & wellness stipend, 401k, parental leave, flexible PTO, commuter benefits, company wide events and more!

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.
For deeper vision, operational excellence, and powerful insights.
Lumafield offers both competitive cash and equity compensation, as well as a health & wellness stipend, 401k, parental leave, flexible PTO, commuter benefits, company wide events and more!
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
Understands the Customer: Able to adapt Lumafield SOPs to satisfy customer requirements in Medical Device, Automotive, Aerospace, and Defense sectors.

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.
Work directly with enterprise customers to demonstrate the robustness of Lumafield's systems, providing technical documentation and assurance for their validation processes.
You can translate complex quality requirements into actionable guidance for engineers and present system validations with clarity and authority to enterprise customers.
Customer Validation: Work directly with enterprise customers to demonstrate the robustness of Lumafield's systems, providing technical documentation and assurance for their validation processes.
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.
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
This includes directly working with customers who need to validate Lumafield's systems inside their own QMS and submissions.
Lumafield was founded in 2019 to upgrade manufacturing.

This listing is sourced directly from Lumafield's careers page and normalized into a canonical job model.