Sr QA Post Market Data Analyst
New
I
Integrated DNA Technologies (IDT)Medical devices
Located remotely within the United States and will be fully remoteFull-TimeSenior
SalaryThe annual salary range OR the hourly range for this role is 83,000.00 - 145,500.00. This job is also eligible for bonus/incentive pay.
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Job Details
- Experience
- 5+ years of experience in quality engineering, quality systems, or post-market surveillance with a strong focus on data analytics and reporting.
- Required Skills
- PythonSQLMicrosoft Power BIMicrosoft ExcelR
Requirements
- 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, focused 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 and Excel.
- Proficiency with statistical analysis software such as Minitab, JMP, R, or Python.
- Ability to travel up to 5% of the time, including occasional overnight travel.
- Ability to work in a remote office environment and use standard computer equipment.
- A master's degree in Engineering, Data Science, Statistics, or a related discipline is a plus.
- Experience in regulated industries such as medical devices, biotechnology, pharmaceuticals, or aerospace is a plus.
- Six Sigma Green Belt, Black Belt, Certified Quality Engineer (CQE), or equivalent quality certification is a plus.
Responsibilities
- Develop, maintain, and automate Power BI dashboards and reports covering 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 for Quality Management Reviews, CAPA programs, management reviews, and regulatory submissions.
- Validate, reconcile, and continuously monitor complaint data to ensure its integrity, accuracy, and governance.
- Partner with Complaint Analysts, Quality Engineers, Regulatory Affairs, IT, Product Development, and Manufacturing teams to investigate quality issues and support corrective and preventive actions.
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