Pearl is the global leader in dental AI, reshaping oral healthcare with tools that raise the standard for diagnostic accuracy, trust, and innovation. Backed by Craft Ventures.
About the role
At Pearl, we take the quality of that software as seriously as the science behind it. The QMS Specialist is the operational backbone of our Quality Management System: the person who keeps our ISO 13485-compliant QMS running day to day, drives CAPA and NCR closure, owns document control in Qualio, and makes sure Pearl can walk into any audit — MDSAP, third-party, or FDA — and walk out clean.
What they're looking for
- 3–5 years of QMS experience in a regulated medical device or SaMD environment
- Hands-on familiarity with ISO 13485, FDA 21 CFR Part 820, and MDSAP, experience with EU MDR and/or Health Canada regulatory requirements is a plus
- Direct experience managing CAPAs, NCRs, and change events in a QMS platform (Qualio experience strongly preferred)
- Experience participating in software release processes in a Quality capacity — able to connect software changes to QMS documentation requirements
- Comfortable owning a live, multi-item compliance queue and maintaining visibility for leadership in weekly reviews
- Strong written communication skills — you can draft a clear SOP, a root cause analysis, and a company-wide training announcement, and they all land differently in the right way
More about this role
Pearl is shaping the future of dentistry with a suite of AI solutions that raise the standard of care for patients worldwide. Since 2019, we've built FDA-cleared computer vision for 2D and 3D dental imagery, used by clinicians, practice owners, labs, and insurers to improve the efficiency, accuracy, and consistency of dental care globally. Our product suite spans Second Opinion, Practice Intelligence, Pearl Insurance, and Scribe, and we serve everyone from independent practices to the largest DSOs in the world.
At Pearl, we take the quality of that software as seriously as the science behind it. The QMS Specialist is the operational backbone of our Quality Management System: the person who keeps our ISO 13485-compliant QMS running day to day, drives CAPA and NCR closure, owns document control in Qualio, and makes sure Pearl can walk into any audit — MDSAP, third-party, or FDA — and walk out clean.
This is a hands-on, execution-heavy role. You'll own a live queue of CAPAs and NCRs at any given time, coordinate cross-functionally with Engineering, Clinical Affairs, and Regulatory, and serve as the Quality owner for software releases — ensuring every release ships with the right...
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