Quality Management Systems Specialist

Job not on LinkedIn

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 10%

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Pearl

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

☁️ SaaS

🤝 B2B

💰 $58M Series B - Pearl on 2024-07

SaaS • B2B

Pearl is a front-end web UI/design toolkit or website template provider. The supplied CSS and class names indicate Pearl maintains a comprehensive design system or set of UI components (navigation, FAQ dropdowns, modals, carousels, responsive containers, accessibility focus states, and testimonial blocks) intended to make marketing and product sites look and behave consistently across browsers and viewports. The materials suggest Pearl offers reusable styles and UX patterns for building or theming websites, though the provided snippet alone does not specify whether Pearl is a template marketplace, design system product, agency, or SaaS platform.

📋 Description

• Own the end-to-end lifecycle for corrective and preventive actions and nonconformance reports in Qualio • Run the CAPA/NCR queue in weekly team meetings and report status, risks, and blockers • Partner with Engineering and other departments on remediation actions • Manage the full document control lifecycle in Qualio • Own change events from initiation through closure and ensure regulatory traceability • Draft, update, and maintain SOPs, work instructions, and policies aligned with ISO 13485, FDA 21 CFR Part 820, and MDSAP • Serve as Quality representative in software release processes and participate in release go/no-go reviews • Maintain release documentation packages, including change events, risk register updates, usability file updates, design history file entries, and required regulatory notifications • Coordinate with Engineering, Regulatory, and Clinical Affairs on quality-relevant release changes • Maintain and improve the release sign-off workflow in Qualio • Coordinate and support internal QMS audits and track corrective actions • Serve as primary QMS contact for third-party and certification body audits • Monitor regulatory landscape changes affecting QMS compliance • Own complaint handling compliance posture and maintain related SOPs and work instructions • Monitor complaint handling activity and escalate trends, documentation gaps, or systemic issues • Provide policy guidance on complaint classification and drive decisions to closure • Coordinate periodic complaint data reviews for CAPA and post-market surveillance signals • Administer the Qualio training module and track completion rates • Drive companywide QMS training campaigns and create Loom walkthroughs and guidance materials • 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 • Ability to connect software changes to QMS documentation requirements • Ability to own a live, multi-item compliance queue and maintain visibility for leadership in weekly reviews • Strong written communication skills • Organized, detail-oriented, and able to manage multiple in-flight items without missing deadlines or documentation • Collaborative and low-ego • Experience supporting MDSAP renewal audits and responding to certification body findings is nice to have • Familiarity with SaMD-specific quality considerations, including software validation, algorithm change protocols, and IEC 62304, is nice to have • Experience evaluating or implementing next-generation QMS platforms is nice to have • Background in post-market surveillance and complaint trend analysis for AI-powered medical devices is nice to have

🏖️ Benefits

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