Quality Management Systems Specialist

📋 Description

• Own the end-to-end lifecycle of corrective and preventive actions (CAPAs) and nonconformance
• Manage the active CAPA/NCR queue, providing regular visibility into status, risks, blockers, and
• Partner with Engineering and other functions to ensure remediation activities are completed on time
• Manage the complete document control lifecycle within the QMS platform, including authoring, review
• Coordinate change events from initiation through closure, ensuring appropriate cross-functional
• Draft, update, and maintain SOPs, work instructions, and policies in alignment with ISO 13485, FDA

🎯 Requirements

• 3–5 years of QMS experience within a regulated medical device or Software as a Medical Device
• Hands-on knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP requirements.
• Experience with EU MDR and/or Health Canada regulatory requirements is a plus.
• Direct experience managing CAPAs, NCRs, and change events through a QMS platform; experience with
• Experience participating in software release processes in a Quality capacity, with the ability to
• Strong organizational skills and the ability to manage multiple active compliance items while

🎁 Benefits

• Full-time, remote position based in the United States.
• Competitive compensation and benefits offerings.
• Flexible, unaccrued paid time off (PTO).
• Ongoing training and professional development opportunities.
• Remote-first work environment.
• Opportunity to contribute to quality systems supporting regulated medical software and AI-enabled