QA Complaint Analyst at Danaher Corporation

Coralville, Iowa, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Genomics, Life SciencesIndustries

Requirements

Bachelor’s degree in Biological Sciences or a 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 (preferred)
Proficiency in Microsoft Office Products (Word, Excel, PowerPoint) or equivalent software applications
Familiarity with ISO 13485, 21 CFR 820, 21 CFR 803, and QSR quality management system requirements and IVD products

Responsibilities

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 complaint investigation processes
Receive and document complaints from various sources, including customers, healthcare professionals, and internal stakeholders
Work closely with cross-functional teams (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

Skills

SAP

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Data Analysis

Complaint Handling

CAPA

SCAR

Quality Investigations

Post-Market Surveillance

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters

1969Year Founded

IPOCompany Stage

Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries

10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.

Potential regulatory challenges in the EU for water quality sector.

Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.

The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.

Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.

Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.

Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

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