Remote QMS Specialist - SaMD ISO13485 Expert

Pearl; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Remote work

Unaccrued, flexible PTO

Ongoing training opportunities

Job summary

Pearl is seeking a QMS Specialist to sustain and improve its ISO 13485-compliant QMS. You will own CAPA/NCRs, manage document control in Qualio, and ensure regulatory readiness for audits (MDSAP, FDA).

The role requires cross-functional collaboration with Engineering, Clinical Affairs, and Regulatory to guarantee release quality and proper documentation. You will also drive QMS platform improvements, onboarding of new tooling, and ongoing training in a remote-first environment.

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; EU MDR/Health Canada knowledge is a plus
• Direct experience managing CAPAs, NCRs, and change events in a QMS platform (Qualio preferred)
• Experience participating in software release processes in a Quality capacity and linking software changes to QMS docs
• Comfortable owning a live, multi-item compliance queue and reporting to leadership weekly
• Strong written communication to draft SOPs, RCAs, and training announcements

Responsibilities

• Own end-to-end lifecycle for corrective and preventive actions and nonconformance reports in Qualio
• Run CAPA/NCR queue as a standing agenda item in weekly team meetings
• Coordinate remediation actions with Engineering and other departments to meet QMS requirements
• Manage the document control lifecycle in Qualio: authoring, routing, approval, release, review
• Coordinate change events from initiation to closure with cross-functional input and regulatory traceability
• Draft and maintain SOPs, work instructions, and policies aligned with ISO 13485 and FDA requirements
• Serve as Quality representative in software release processes and ensure QMS coverage before sign-off
• Maintain release documentation packages including risk and usability files
• Coordinate with Engineering/Regulatory/Clinical Affairs to identify quality-relevant changes
• Maintain and improve release sign-off workflow in Qualio for traceability

Job description

Pearl is seeking a QMS Specialist to sustain and improve its ISO 13485-compliant QMS. You will own CAPA/NCRs, manage document control in Qualio, and ensure regulatory readiness for audits (MDSAP, FDA).

The role requires cross-functional collaboration with Engineering, Clinical Affairs, and Regulatory to guarantee release quality and proper documentation. You will also drive QMS platform improvements, onboarding of new tooling, and ongoing training in a remote-first environment.