QMS Specialist at Pearl

About Pearl

Pearl is shaping the future of dentistry with a suite of AI solutions that raise the standard of care for patients worldwide. Since 2019, they’ve built FDA-cleared computer vision for 2D and 3D dental imagery, used by clinicians, practice owners, labs, and insurers to improve efficiency, accuracy, and consistency in dental care globally. Their product suite includes Second Opinion, Practice Intelligence, Pearl Insurance, and Scribe, serving everyone from independent practices to the largest DSOs.

The Role

At Pearl, quality of software is as critical as the science behind it. The QMS Specialist serves as the operational backbone of their ISO 13485-compliant Quality Management System (QMS), ensuring day-to-day operations run smoothly, driving CAPA (Corrective and Preventive Action) and NCR (Nonconformance Report) closure, managing document control in Qualio, and preparing Pearl for audits—whether MDSAP, third-party, or FDA—ensuring a clean exit.

This is a hands-on, execution-heavy role. You’ll own a live queue of CAPAs and NCRs, coordinate cross-functionally with Engineering, Clinical Affairs, and Regulatory, and act as the Quality owner for software releases, ensuring every release ships with the right documentation and QMS coverage. You’ll also play a significant role in QMS platform management and continuous improvement, including evaluating and onboarding next-generation QMS tooling.

Key Responsibilities

CAPA & NCR Management

• Own the end-to-end lifecycle for corrective and preventive actions and nonconformance reports in Qualio, including initiation, root cause investigation, action plan development, implementation tracking, and verification of effectiveness.
• Run the CAPA/NCR queue as a standing agenda item in weekly team meetings, keeping the team updated on status, risks, and blockers.
• Partner with Engineering and other departments on remediation actions, ensuring task timeliness and documentation meets QMS requirements.

Document Control & Change Management

• Manage the full document control lifecycle in Qualio, including authoring, review routing, approval, release, and periodic review.
• Own change events from initiation through closure, coordinating cross-functional input and ensuring regulatory traceability.
• Draft, update, and maintain SOPs (Standard Operating Procedures), work instructions, and policies in alignment with ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements.

Software Release Quality Coordination

• Serve as the Quality representative in the software release process, participating in release go/no-go reviews and ensuring QMS requirements are satisfied before sign-off.
• Own and maintain the release documentation package, ensuring change events, risk register updates, usability file updates, design history file entries, and regulatory notifications are complete and linked prior to each release.
• Coordinate with Engineering, Regulatory, and Clinical Affairs to identify quality-relevant changes in each release and confirm appropriate documentation coverage.
• Maintain and improve the release sign-off workflow in Qualio, ensuring traceability between software changes and QMS records.

Internal Audits & Regulatory Readiness

• Coordinate and support internal QMS audits, tracking findings and ensuring follow-through on corrective actions.
• Serve as the primary QMS point of contact for third-party and certification body audits (e.g., MDSAP, ISO/MDR), preparing documentation packages and responding to findings.
• Monitor the regulatory landscape for changes affecting QMS compliance requirements.

Complaint Handling Oversight

• Own Pearl's complaint handling compliance posture, ensuring the complaint handling SOP and associated work instructions are current, understood, and consistently followed.
• Monitor complaint handling activity for policy adherence, escalating trends, documentation gaps, or systemic issues.
• Serve as the policy authority for complaint classification questions, providing guidance to complaint handlers and driving decisions to closure.
• Coordinate periodic complaint data reviews to surface quality signals for CAPA consideration and post-market surveillance reporting.

Training & QMS Administration

• Administer the Qualio training module, track completion rates across the organization, and follow up on outstanding assignments to maintain compliance targets.
• Drive company-wide QMS training campaigns, creating Loom walkthroughs and guidance materials to support staff in a remote-first environment.
• Evaluate and support onboarding of new QMS platform capabilities, such as SBOM (Software Bill of Materials) management, vulnerability tracking, and dependency management.