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Director of Quality Compliance & Validation Strategy

Lumafield

Job Location:

Boston, MA - USA

Yearly Salary: USD 160000 - 210000

Posted: 12 June 2026 (30+ days ago)

Application Deadline: 3 December 2026

Vacancies: 1 Vacancy

Job Summary

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. Were building for greater intelligence autonomy and speed. For deeper vision operational excellence and powerful insights. And then well 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.

Lumafields 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 ISOCFR 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. Youll also guide customers and support validation of our systems and lead customer audits.

What youll do:

Own the QMS: Design implement and maintain a unified QMS that covers the full scope of Lumafields operations ensuring scalability and adherence to international quality standards.
Lead Compliance Initiatives: Lead Lumafields 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 Lumafields 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 Lumafields 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 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

Bonus points:

Direct experience as a Lead Auditor (ISO 9001 ISO 13485 or ISO/IEC 17025) or ASQ CQA / CQE certification.
Experience with FDA 21 CFR Part 820 EU MDR IATF 16949 AS9100 or NADCAP.
Hands-on background with industrial CT CMM or other dimensional metrology systems and the GD&T workflows they support.
Prior experience standing up a calibration lab or ISO/IEC 17025 scope from scratch.
Experience supporting customers through their own regulatory filings (510(k) PMA) using data generated on a vendors equipment.
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

$160000 - $210000 a year

The base salary range listed here represents the anticipated low and high end of the salary range for this position. Actual salaries may vary and may be above or below the range based on various factors including but not limited to work location experience and performance. All full time employees receive an equity grant.

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!

Lumafield is committed to building a team that represents a variety of backgrounds perspectives and skills because the more inclusive we are the better our work will be. Do you feel like your skills dont meet every single requirement listed We encourage you to apply anyway If youre excited about our technology the opportunity and are eager to learn more wed love to hear from you!

In keeping with our beliefs and goals no employee or applicant will face discrimination or harassment based on: race color ancestry national origin religion age gender marital domestic partner status sexual orientation gender identity disability genetic information or veteran status.

Reach out if you want to be a part of what we are building.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Director

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