Quality Assurance Manager - Remote

Overview

The Quality Assurance Manager is responsible for overseeing and continually enhancing the organization's quality systems, ensuring full compliance with applicable FDA regulations.

In Short

• Manage the electronic Quality Management System (eQMS).
• Oversee document control and compliance training.
• Handle product complaints and investigations.
• Conduct internal audits and support regulatory inspections.
• Generate and analyze quality KPIs.
• Collaborate with various teams to meet quality objectives.
• Maintain inspection readiness of quality records.
• Develop training on quality processes for internal users.
• Monitor non-conformances and CAPA activities.
• Approve and review quality documents.

Requirements

• Experience in quality assurance and regulatory compliance.
• Knowledge of FDA regulations under 21 CFR Parts 111 and 117.
• Strong analytical and problem-solving skills.
• Excellent communication and training abilities.
• Ability to conduct audits and inspections.
• Familiarity with quality management systems.

Benefits

• Dynamic and purpose-driven work environment.
• Opportunities for professional growth.
• Access to high-quality health supplements.
• Recognition as a top workplace in Austin.