Quality Assurance Specialist

Requirements:

• Associate's degree preferred
• 2+ years of relevant experience in customer service, complaint handling, quality assurance, product recalls, or documentation management
• Experience in a regulated industry, preferably medical device or pharmaceutical
• Strong verbal and written communication skills with experience providing phone and email support
• Experience handling customer complaints, product inquiries, or recall-related issues
• Strong attention to detail and documentation skills in a regulated environment
• Proficiency with Microsoft Office, including Outlook, Word, and Excel
• Ability to learn and navigate internal tracking and reporting systems
• Organized, adaptable, and able to manage multiple customer interactions and priorities
• Professional, customer-focused phone presence with the ability to communicate clearly and provide detailed instructions
• Experience maintaining accurate records and documentation in accordance with FDA requirements

Preferred:

• Experience with Zendesk, Genesys, or similar customer support platforms
• Medical device, pharmaceutical, distribution, or retail customer support experience
• Experience generating and analyzing reports
• Familiarity with FDA regulations, including FDA 21 CFR 806 and ISO 13485

Position Summary:

Insight Global is seeking detail-oriented professionals to support an established medical device client in the Mundelein, IL area. This team serves as the primary point of contact for customer complaints, product inquiries, and recall-related activities. Individuals will provide phone and email support, coordinate product return processes, maintain detailed documentation, and ensure regulatory compliance with FDA requirements.

Key Responsibilities:

• Provide phone and email support for customer complaints, inquiries, and product recall activities
• Document all customer interactions accurately and thoroughly in compliance with FDA regulations
• Coordinate product returns, including issuing return labels, RGAs, credits, and replacement products
• Review and respond to internal and external inquiries within established timelines
• Process and track complaint and recall documentation through internal systems
• Execute and coordinate recall and sub-recall activities in accordance with internal procedures
• Maintain complete, organized, and audit-ready records for all complaints and recall activities
• Generate and review reports related to complaint volumes, recall activity, and operational metrics
• Partner with Quality Assurance, Quality Control, and cross-functional teams to investigate and resolve issues
• Provide guidance to internal teams regarding affected or recalled products
• Ensure timely customer follow-up and resolution while maintaining a positive, professional customer experience
• Adapt to changing priorities and support a high-volume customer environment

Schedule: Monday-Friday, 8AM-5PM CST

Location: Mundelein, IL (onsite 3x per week)

Compensation: $20-$23/ hour