Quality Associate

Job Summary

Detail-oriented and organized, the full-time remote Quality Associate will manage post-market surveillance, complaint handling, document control, and audit support while collaborating with cross-functional teams to ensure compliance with quality standards in the medical device industry.

Key Responsibilities

• Review and initiate the complaint process for patient feedback, ensuring compliance with FDA and ISO 13485 requirements
• Oversee document control activities, maintaining current and audit-ready quality management system documentation
• Assist with internal audits and support corrective and preventive actions (CAPA) documentation and tracking

Required Qualifications

• Bachelor's degree required; Master's degree in Regulatory Affairs, Quality Systems, or a related field preferred
• Minimum of 2 years of experience in the medical device industry, familiar with FDA 21 CFR 820 and ISO 13485
• Experience with complaint handling and document control or QMS software is strongly preferred
• Experience supporting internal audits or CAPA processes is a plus
• Proficient in Microsoft Office suite with excellent organizational skills and attention to detail