Quality Management Systems Specialist

Job Summary

To support a growing compliance department, the full-time Quality Management Systems Specialist will manage the ISO 13485-compliant Quality Management System, oversee CAPA and NCR processes, and ensure quality coordination for software releases in a remote work environment.

Key Responsibilities

• Own the end-to-end lifecycle of CAPAs and NCRs, coordinating with cross-functional teams to ensure timely resolution and compliance
• Manage document control processes in Qualio, including authoring, approval, and periodic review of SOPs and work instructions
• Serve as the Quality representative during software release processes, ensuring all QMS requirements are met before sign-off

Required 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
• Direct experience managing CAPAs, NCRs, and change events in a QMS platform, preferably Qualio
• Experience in software release processes with a focus on QMS documentation requirements
• Strong written communication skills for drafting SOPs and conducting training