Quality Management Systems Specialist

Summary

Pearl is shaping the future of dentistry with a suite of AI solutions that raise the standard of care for patients worldwide. The Quality Management Systems Specialist will serve as the operational backbone of Pearl's ISO 13485-compliant QMS, managing CAPAs, NCRs, document control, audits, complaint handling oversight, and training administration. The role also partners cross-functionally with Engineering, Clinical Affairs, and Regulatory to ensure software releases and QMS processes meet regulatory requirements.

Responsibilities

• Own end-to-end lifecycle for corrective and preventive actions and nonconformance reports in Qualio: 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; keep the team current on status, risks, and blockers
• Partner with Engineering and other departments on remediation actions, ensuring task timeliness and documentation meets QMS requirements
• Manage the full document control lifecycle in Qualio: 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, work instructions, and policies in alignment with ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements
• 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: ensure change events, risk register updates, usability file updates, design history file entries, and any required 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
• 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 (MDSAP, ISO/MDR); prepare documentation packages and respond to findings
• Monitor the regulatory landscape for changes affecting QMS compliance requirements
• Own Pearl's complaint handling compliance posture: ensure the complaint handling SOP and associated work instructions are current, understood, and consistently followed across the organization
• Monitor complaint handling activity for policy adherence — escalating trends, documentation gaps, or systemic issues — without owning individual complaint investigations
• Serve as the policy authority for complaint classification questions (complaint vs. feedback, native integration edge cases, etc.), 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
• Administer the Qualio training module; track completion rates across the organization and follow up on outstanding assignments to maintain compliance targets
• Drive companywide QMS training campaigns; create Loom walkthroughs and guidance materials to support staff in a remote-first environment
• Evaluate and support onboarding of new QMS platform capabilities (e.g., SBOM management, vulnerability tracking, dependency management)

Skills

• • 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
• • Organized, detail-oriented, and able to manage multiple in-flight items without dropping the ball on deadlines or documentation
• • Collaborative and low-ego — this role touches almost every team at Pearl, and success depends on relationships as much as process knowledge
• • 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

Qualifications

Must Haves

• • 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
• • Organized, detail-oriented, and able to manage multiple in-flight items without dropping the ball on deadlines or documentation
• • Collaborative and low-ego — this role touches almost every team at Pearl, and success depends on relationships as much as process knowledge

Nice to Haves

• • 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

Benefits

• Ongoing training and development opportunities
• Unaccrued, flexible PTO
• Remote work