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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Quality Management Systems Specialist - **Company:** Pearl, Inc. - **Location:** United States (Remote available) - **Experience:** Experienced - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, Document Management Systems, Software Engineering, Verification and Validation (Software), Mdsap - **Published:** September 24, 2026 - **Apply:** https://startup.jobs/quality-management-systems-specialist-hellopearl-com-10163434 ## About the Role * 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 ## 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., 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) ## Related Videos - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [The Avengers Initiative (Practical Ethics for Software Engineers)](https://www.wearedevelopers.com/videos/2070-the-avengers-initiative-practical-ethics-for-software-engineers) - [Edit Your Future: Queerverse Radical AI](https://www.wearedevelopers.com/videos/909-edit-your-future-queerverse-radical-ai) - [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible) - [Official Opening of WeAreDevelopers World Congress 2026](https://www.wearedevelopers.com/videos/100000-official-opening-of-wearedevelopers-world-congress-2026) - [AI is dead, long live AK](https://www.wearedevelopers.com/videos/1093-ai-is-dead-long-live-ak) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Trustworthy AI Starts at Deployment: 5 Checks Before You Ship](https://www.wearedevelopers.com/magazine/753-trustworthy-ai-starts-at-deployment-5-checks-before-you-ship) - [13 AI Tools You Have to Try](https://www.wearedevelopers.com/magazine/219-13-ai-tools-you-have-to-try) - [Dev Digest 129 - Now that's what I call private data!](https://www.wearedevelopers.com/magazine/468-dev-digest-129-now-that-s-what-i-call-private-data) - [Dev Digest 121 - AI goes offline](https://www.wearedevelopers.com/magazine/456-dev-digest-121-ai-goes-offline)