Danaher Corporation-posted 8 months ago
5,001-10,000 employees

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team. IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. This position is part of the Quality Assurance Department located in Coralville, IA and will be on-site. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.

  • Contribute to the continuous improvement of product safety and compliance by effectively managing and resolving quality complaints.
  • Communicate with internal team members and external customers to facilitate the 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.
  • Bachelor's degree in Biological Sciences or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry).
  • 1 - 2 years of related experience in post-market product surveillance and complaint handling.
  • Proficient in data analysis and workflow troubleshooting, including instrumentation, arrays, and biological materials.
  • Experience with SAP is preferred.
  • Proficiency in Microsoft Office Products (Word, Excel, PowerPoint) or equivalent software applications is preferred.
  • Familiarity with ISO 13485, 21 CFR 820, 21 CFR 803, and QSR quality management system requirements and IVD products.
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