Director of Regulatory Compliance & Validation Strategy
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Overview
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.
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 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.
- Customer Validation: Work directly with enterprise customers to demonstrate the robustness of Lumafield’s 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 Lumafield’s 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 vendor’s 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
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