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Danaher

Makes tools for drug research and medical testing

Quality Assurance Complaint Analyst

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeCoralville, IA, USANo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree in Biological Sciences or a related field, such as Biomedical Engineering, Systems Engineering, Pharmacology, or Chemistry.
  • At least 1 year 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.

Responsibilities

  • Contribute to 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 customers, healthcare professionals, and internal stakeholders.
  • Work with Scientific Application Support, Quality Assurance, Regulatory Affairs, Product Development, and Manufacturing teams to investigate and resolve complaints.
  • Support quality system investigations, including issue reviews, nonconformances, corrective and preventive actions, and supplier corrective action requests.

Desired Qualifications

  • 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 requirements, and in vitro diagnostic products.

About the Company

Danaher

Makes tools for drug research and medical testing

Danaher makes instruments, tests and laboratory supplies for drug developers, researchers and clinicians, spanning the path from biological research to clinical patient diagnosis. Its businesses include Cytiva for drug manufacturing, SCIEX for chemical analysis and Beckman Coulter for laboratory testing, linking specialized tools across healthcare workflows. Customers use its equipment to study cells, produce biological medicines and analyze patient samples; the group earns money by selling instruments, reagents, software and support services through its operating companies. Danaher was established in 1984 and is headquartered in Washington, DC.

Company size
10,001+
Company stage
IPO
Headquarters
Washington, DC
Founded
1984

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