Quality Analyst

Job Summary

To support quality and regulatory compliance, the fully remote Quality Analyst will manage customer complaints, ensure adherence to medical device regulations, and collaborate with cross-functional teams to enhance the customer experience.

Key responsibilities

• Analyze and process complaints to ensure proper coding and assessment in compliance with regulations
• Coordinate complaint investigations and maintain partnerships with internal and external stakeholders to identify risks and improvement opportunities
• Document and track critical quality issues while implementing formal escalation processes for product quality and regulatory compliance

Required qualifications

• Bachelor's degree or equivalent experience with a minimum of 2+ years in data management and troubleshooting within the medical device field
• At least 3+ years of experience processing complaints in the device or pharmaceutical/life-sciences industry
• Demonstrated knowledge of global medical device and pharmacovigilance regulations
• Experience with domestic and international regulatory reporting requirements for medical devices
• Proficiency in Microsoft Office programs, particularly Excel, PowerPoint, and Word