Senior QA & Post-Market Analytics Lead (Remote)

Danaher Corporation; Austin (TX); Teletrabalho; USD 83 000 - 146 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Bonus eligibility

Resumo da oferta

Integrated DNA Technologies (IDT) is seeking a Senior Quality Engineer – Post Market Data Analyst to transform post-market surveillance data into actionable insights that drive product quality, patient safety, regulatory compliance, and continuous improvement.

This remote US role reports to the Sr. Quality Assurance Manager and focuses on developing BI dashboards, performing advanced analyses, and supporting CAPA and QMR processes to enhance global quality programs.

Qualificações

• Bachelor’s degree in Engineering, Data Science, Statistics, Quality Engineering, or a related technical field.
• 5+ years of experience in quality engineering, quality systems, or post-market surveillance with a strong focus on data analytics and reporting.
• Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, Quality System Regulations, and medical device or IVD quality requirements.
• Experience developing dashboards and reports using Power BI and advanced data analysis tools.
• Proficiency with SQL, Excel, and statistical analysis software such as Minitab, JMP, R, or Python.

Responsabilidades

• Develop, maintain, and automate Power BI dashboards and reports that provide visibility into complaint trends, closure rates, aging metrics, and risk indicators.
• Perform advanced statistical analyses using quality engineering tools and methodologies to identify emerging signals, recurring issues, and systemic risks.
• Generate and communicate trend reports and quality metrics to support QMRs, CAPA programs, management reviews, and regulatory submissions.
• Ensure integrity, accuracy, and governance of complaint data through validation, reconciliation, and continuous monitoring processes.
• Partner with Complaint Analysts, Quality Engineers, Regulatory Affairs, IT, Product Development, and Manufacturing teams to investigate quality issues and support corrective and preventive actions.

Conhecimentos

Power BI

SQL

Excel

Minitab

JMP

R

Python

Formação académica

Bachelor’s degree in Engineering, Data Science, Statistics, Quality Engineering, or a related technical field

Master’s degree in Engineering, Data Science, Statistics, or related discipline

Six Sigma Green Belt, Black Belt, CQE or equivalent quality certification

Ferramentas

Power BI

Descrição da oferta de emprego

Integrated DNA Technologies (IDT) is seeking a Senior Quality Engineer – Post Market Data Analyst to transform post-market surveillance data into actionable insights that drive product quality, patient safety, regulatory compliance, and continuous improvement.

This remote US role reports to the Sr. Quality Assurance Manager and focuses on developing BI dashboards, performing advanced analyses, and supporting CAPA and QMR processes to enhance global quality programs.