[Hiring] Quality Management Systems Specialist @Pearl

Role Description

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 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 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.
• Document Control & Change Management
  • 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.
• 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: 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.
• 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 (MDSAP, ISO/MDR); prepare documentation packages and respond to findings.
  • Monitor the regulatory landscape for changes affecting QMS compliance requirements.
• Complaint Handling Oversight
  • 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.
• 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 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).

Qualifications

• 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 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.

Benefits

• Competitive benefit and compensation offerings.
• Ongoing training and development opportunities.
• Unaccrued, flexible PTO.
• Remote work.