Own the QMS across Lumafield's operations; ensure scalability and standards.
Lead ISO 9001 and ISO/IEC 17025 programs; prep for new certifications.
Work with enterprise customers to validate systems; provide docs.
Advise Product/Engineering for fully validated solutions in regulated industries.
Primary contact for audits, regulatory inspections, and internal assessments.
Partner with cross-functional teams to guide regulatory QA and success.

🎯 Requirements

10+ years managing quality systems in regulated environments (medical devices).
Hands-on ISO 9001, ISO 17025, 21 CFR Part 11, CSV, IQ/OQ/PQ.
Understands ISO 13485 and 21 CFR Part 820 for medical devices.
Strategic thinker balancing rigorous QA with startup agility.
Excellent communicator translating QA requirements to engineers and customers.
Collaborative, cross-functional leader enabling speed and innovation.

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