QA Complaint Analyst

Location: Coralville, Iowa, United States; on-site role

Company

hirify.global is a life sciences and biotechnology group whose operating company Integrated DNA Technologies develops genomics and research solutions.

What you will do

• Manage and resolve customer complaints related to product quality, safety, and compliance.
• Receive, document, and track complaints from customers, healthcare professionals, and internal stakeholders.
• Communicate with internal teams and external customers throughout complaint investigations.
• Work with Scientific Application Support, Quality Assurance, Regulatory Affairs, Product Development, and Manufacturing to investigate product issues.
• Support quality system investigations, including issue reviews, nonconformances, CAPAs, and SCARs.

Requirements

• Bachelor’s degree in Biological Sciences or a related field such as Biomedical Engineering, Systems Engineering, Pharmacology, or Chemistry.
• At least 1 year of experience in post-market product surveillance and complaint handling.
• Experience conducting investigations and documenting results within a regulated quality system environment.
• Experience working with cross-functional teams to resolve product quality issues.
• Experience maintaining quality records and supporting quality system processes.

Nice to have

• Data analysis and workflow troubleshooting experience involving instrumentation, arrays, and biological materials.
• Experience with SAP and Microsoft Office applications, including Word, Excel, and PowerPoint.
• Familiarity with ISO 13485, 21 CFR Part 820, 21 CFR Part 803, QSR requirements, and in vitro diagnostic products.

Culture & Benefits

• Culture focused on collaboration, scientific excellence, continuous learning, and continuous improvement.
• Comprehensive benefits, including healthcare programs and paid time off.
• Opportunity to contribute to genomics, life sciences, diagnostics, and biotechnology research.