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Pearl is an AI-driven dental technology company that has developed FDA-cleared computer vision solutions for 2D and 3D dental imagery. The company serves clinicians, practice owners, labs, and insurers globally, with products spanning Second Opinion, Practice Intelligence, Pearl Insurance, and Scribe.
The Quality Management Systems Specialist is the operational backbone of Pearl's QMS, responsible for maintaining ISO 13485 compliance and ensuring the company can successfully navigate FDA, MDSAP, and third-party audits. This is a hands-on, execution-heavy role that requires deep engagement across Engineering, Clinical Affairs, and Regulatory teams.
Key responsibilities include:
**CAPA & NCR Management**: Own the complete lifecycle of corrective and preventive actions and nonconformance reports in Qualio, from initiation through root cause investigation, action plan development, implementation tracking, and effectiveness verification. Manage the CAPA/NCR queue as a standing agenda item in weekly team meetings and partner with Engineering and other departments on remediation actions.
**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 and draft, update, and maintain SOPs, work instructions, and policies aligned 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 go/no-go reviews and ensuring QMS requirements are satisfied before sign-off. Own and maintain the release documentation package, including change events, risk register updates, usability files, and design history file entries. Coordinate with Engineering, Regulatory, and Clinical Affairs to identify quality-relevant changes and confirm appropriate documentation coverage.
**Internal Audits & Regulatory Readiness**: Coordinate and support internal QMS audits, track findings, and ensure follow-through on corrective actions. Serve as the primary QMS point of contact for third-party and certification body audits, prepare documentation packages, and respond to findings. Monitor the regulatory landscape for changes affecting QMS compliance.
**Complaint Handling Oversight**: Own Pearl's complaint handling compliance posture, ensure the complaint handling SOP and associated work instructions are current and consistently followed, monitor complaint handling activity for policy adherence, and serve as the policy authority for complaint classification questions. Coordinate periodic complaint data reviews to surface quality signals for CAPA consideration.
**Training & QMS Administration**: Administer the Qualio training module, track completion rates, and drive companywide QMS training campaigns. Evaluate and support onboarding of new QMS platform capabilities.
**Requirements**:
- 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; able to draft clear SOPs, root cause analyses, and company-wide training announcements
- Organized, detail-oriented, and able to manage multiple in-flight items without dropping the ball on deadlines or documentation
- Collaborative and low-ego; success depends on relationships as much as process knowledge
**Nice to Have**:
- Experience supporting MDSAP renewal audits and responding to certification body findings
- Familiarity with SaMD-specific quality considerations (e.g., software validation, algorithm change protocols, IEC 62304)
- Experience evaluating or implementing next-generation QMS platforms beyond legacy document management systems
- Background in post-market surveillance and complaint trend analysis for AI-powered medical devices
