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QA Complaint Analyst

Danaher Corporation Office Usa

Complaint AnalystBring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Integrated DNA Technologies (IDT), one of Danaher's operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.Our team at Integrated DNA Technologies (IDT) is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you'll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all.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 complaintsCommunicate 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.The essential requirements of the job include: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.It would be a plus if you also possess previous experience in: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.IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Danaher Corporation

Vacancy posted 2 days ago
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