Quality Management Systems Specialist

📋 Description

• Own end-to-end lifecycle for corrective and preventive actions and nonconformance reports
• Run CAPA/NCR queue as standing agenda in weekly team meetings
• Partner with Engineering and other departments on remediation actions
• Manage full document control lifecycle in Qualio (authoring, review routing, approval, release
• Own change events from initiation through closure, ensuring regulatory traceability
• Draft, update, and maintain SOPs, work instructions, and policies aligned with ISO 13485, FDA 21

🎯 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
• Experience participating in software release processes in a Quality capacity
• Comfortable owning a live, multi-item compliance queue and maintaining visibility for understanding

🎁 Benefits

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