Senior Quality Engineer – Post Market Data Analyst

Job not on LinkedIn

🔥 13 minutes ago

🇺🇸 United States – Remote

💵 $66k - $115.5k / year

⏰ Full Time

🟠 Senior

📊 Analytics Engineer

🦅 H1B Visa Sponsor

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Logo of Danaher Corporation

Danaher Corporation

10,000+ employees

🧬 Biotechnology

🔬 Science

🤝 B2B

Biotechnology • Science • B2B

Danaher Corporation is a leading global life sciences and diagnostics innovator that develops and supplies instruments, technologies, software, and services to accelerate scientific research, biotechnology development, and clinical diagnostics. The company operates through businesses focused on biotechnology tools, diagnostics platforms, and life sciences products, leveraging the Danaher Business System and an acquisition-driven strategy to scale technologies and support customers across academia, pharmaceutical and biotech companies, and clinical laboratories.

📋 Description

• Develop, maintain, and automate complaint analytics dashboards, reports, and statistical trend analyses to monitor quality performance, identify emerging signals, and support Quality Management Reviews, CAPA activities, and business decision-making. • Ensure the integrity, accuracy, and governance of complaint and quality system data through validation, reconciliation, audit trail management, and continuous improvement of reporting processes. • Provide data-driven support for complaint investigations, root cause analysis, risk management activities, and CAPA effectiveness evaluations to strengthen product quality and patient safety outcomes. • Collaborate with Quality Assurance, Regulatory Affairs, Scientific Application Support, Product Development, Manufacturing, Process Engineering, and other cross-functional stakeholders to identify trends and drive continuous improvement initiatives. • Support regulatory compliance, internal and external audits, and inspections through accurate reporting, analysis, documentation, and application of quality system requirements.

🎯 Requirements

• Bachelor's degree in Engineering, Data Science, Statistics, Computer Science, Quality, or a related technical discipline with 5+ years of relevant experience, OR a Master's degree in a related field with 3+ years of relevant experience • Experience developing and maintaining business intelligence and reporting solutions using Power BI, Tableau, or similar data visualization platforms. • Proficiency in statistical analysis and data management tools, including SQL and Microsoft Excel, with experience using Minitab, JMP, R, or Python. • Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, CAPA, complaint handling, risk management processes, and Quality Management System requirements.

🏖️ Benefits

• Health care program • Paid time off • Medical/dental/vision insurance • 401(k)

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