Senior Quality Management System Specialist - Remote

Overview

We are seeking a detail-oriented and experienced Sr. Quality Management System (QMS) Specialist to ensure compliance with regulatory requirements and industry standards in our growing AI software company.

In Short

• Develop, implement, and maintain the Quality Management System.
• Ensure QMS documentation is up to date and aligned with regulatory changes.
• Support internal and external audits.
• Oversee the Corrective and Preventive Actions (CAPA) process.
• Support QA/RA and engineering teams for software compliance.
• Conduct QMS training for employees.
• Monitor QMS effectiveness and recommend improvements.
• Track and analyze quality metrics.
• Manage document control system.
• Promote a culture of quality and continuous improvement.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years of experience in quality management for medical devices.
• Strong understanding of ISO 13485, FDA 21 CFR Part 820, IEC 62304.
• Experience with internal/external audits and CAPA management.
• Knowledge of software development lifecycle (SDLC).
• Strong analytical and problem-solving skills.
• Excellent attention to detail.
• Effective communication skills.
• Proficiency in QMS software tools.

Benefits

• Competitive salary and equity options.
• Comprehensive health, dental, and vision benefits.
• Flexible remote work environment.
• Professional development opportunities.
• A collaborative and innovative team.