Hiring: Director of Quality Compliance & Validation Strategy Company: Lumafield Location: Boston, MA Job Posted Time: 2026-09-16 12:19:37 Employment Type: Full-time Target Skills & Keywords : AI, Computer Vision, Quality Assurance About the job Experience: •10+ years of experience with a proven track record of managing quality systems in highly technical or regulated environments, particularly in medical devices Required Skills: •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. •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. •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 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. •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 Qualifications: •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 •Able to adapt Lumafield SOPs to satisfy customer requirements in Medical Device, Automotive, Aerospace, and Defense sectors. Understands ISO 13485 & 21 CFR Part 820. •You understand how to balance the need for rigorous quality processes with the agility required in a fast-growing startup. •You can translate complex quality requirements into actionable guidance for engineers and present system validations with clarity and authority to enterprise customers. •You enjoy working cross-functionally and view the Quality function as an enabler of speed and innovation •Direct experience as a Lead Auditor (ISO 9001, ISO 13485, or ISO/IEC 17025) or ASQ CQA / CQE certification. •Hands-on background with industrial CT, CMM, or other dimensional metrology systems, and the GD&T workflows they support. Compensation: •$160,000 - $210,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!