Remote Senior QA Data Analyst – Post-Market Quality Insights

Regulatory Jobs; United States; A distancia; USD 83.000 - 146.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus eligible

Descripción de la vacante

Integrated DNA Technologies (IDT) is seeking a Senior Quality Engineer – Post Market Data Analyst to transform post‑market data into actionable insights. Remote within the United States, reporting to the Senior QA Manager, you will build BI dashboards, perform advanced analytics, and support regulatory submissions to enhance product quality and patient safety.

Key requirements include a Bachelor's in engineering or related field, 5+ years in quality engineering with data analytics, and

Formación

• 5+ years in quality engineering or post-market surveillance with data analytics focus.
• Knowledge of ISO 13485 and 21 CFR parts; medical device/IVD quality requirements.
• Experience building dashboards/reports with Power BI and advanced analytics.
• Proficiency in SQL, Excel, and statistical tools (Minitab/JMP/R/Python).

Responsabilidades

• Develop, maintain, and automate Power BI dashboards for complaint trends and risk indicators.
• Apply advanced statistics to identify signals, recurring issues, and systemic risks.
• Generate trend reports for QMRs, CAPA, and regulatory submissions.
• Ensure data integrity and governance of complaint data via validation and reconciliation.
• Collaborate with QA, Regulatory, IT, and Manufacturing to drive CAPA actions.

Conocimientos

Data analytics

Quality engineering

Statistical analysis

ISO regulatory knowledge

Educación

Bachelor's degree in Engineering

Master's degree

Herramientas

Power BI

SQL

Excel

Minitab

JMP

R

Python

Descripción del empleo

Integrated DNA Technologies (IDT) is seeking a Senior Quality Engineer – Post Market Data Analyst to transform post‑market data into actionable insights. Remote within the United States, reporting to the Senior QA Manager, you will build BI dashboards, perform advanced analytics, and support regulatory submissions to enhance product quality and patient safety.

Key requirements include a Bachelor's in engineering or related field, 5+ years in quality engineering with data analytics, and