QA Complaint Analyst
About The Position
The Complaint Analyst is responsible for supporting product quality, safety, and regulatory compliance through effective management of customer complaints and post-market surveillance activities. This role partners with cross-functional teams to investigate product-related issues, support quality system processes, identify root causes, and drive continuous improvement efforts that enhance customer satisfaction and product performance. This position reports to the Quality Assurance Manager, Complaints and is part of the Quality Assurance Department located in Coralville, IA and will be an on-site role. In this role, you will have the opportunity to: Contribute to the continuous improvement of product safety +compliance by effectively managing and resolving quality complaints Communicate with internal team members and external customers to facilitate complaint investigation process. Receive and document complaints from various sources, including customers, healthcare professionals, and internal stakeholders. Work closely with cross-functional teams, including Scientific Application Support (SAS), Quality Assurance, Regulatory Affairs, Product Development, and Manufacturing to investigate and resolve complaints. Support quality system investigations, including issue reviews, nonconformances, CAPAs, SCARs, as needed.
Requirements
- Bachelor's degree in Biological Sciences or a related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry).
- 1+ years of related 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 Haves
- Proficiency in data analysis and workflow troubleshooting, including instrumentation, arrays, and biological materials.
- Experience with SAP and proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint, or equivalent software applications.
- Familiarity with ISO 13485, 21 CFR Part 820, 21 CFR Part 803, Quality System Regulation (QSR) requirements, and in vitro diagnostic (IVD) products.
Responsibilities
- Manage and resolve quality complaints.
- Communicate with internal team members and external customers to facilitate complaint investigation process.
- Receive and document complaints from various sources, including customers, healthcare professionals, and internal stakeholders.
- Work closely with cross-functional teams, including Scientific Application Support (SAS), Quality Assurance, Regulatory Affairs, Product Development, and Manufacturing to investigate and resolve complaints.
- Support quality system investigations, including issue reviews, nonconformances, CAPAs, SCARs, as needed.
Benefits
- Health care program
- Paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
