Sr QA Post Market Data Analyst
Role Overview
The Senior Quality Engineer – Post Market Data Analyst turns post-market surveillance and complaint-handling data into insights for product quality, patient safety, regulatory compliance, and continuous improvement.
The role reports to the Senior Quality Assurance Manager within Quality Assurance and Regulatory Affairs.
The position is fully remote within the United States.
Key Skills for This Role
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About IDT
Integrated DNA Technologies is a Danaher operating company focused on genomics and life-science research.
Role overview
The Senior Quality Engineer – Post Market Data Analyst turns post-market surveillance and complaint-handling data into insights for product quality, patient safety, regulatory compliance, and continuous improvement.
The role reports to the Senior Quality Assurance Manager within Quality Assurance and Regulatory Affairs.
The position is fully remote within the United States.
Responsibilities
- Develop, maintain, and automate Power BI dashboards and reports on complaint trends, closure rates, aging metrics, and risk indicators.
- Use advanced statistical and quality engineering methods to identify emerging signals, recurring issues, and systemic risks.
- Communicate trend reports and quality metrics for Quality Management Reviews, CAPA programs, management reviews, and regulatory submissions.
- Validate, reconcile, and continuously monitor complaint data for integrity, accuracy, and governance.
- Partner cross-functionally to investigate quality issues and support corrective and preventive actions.
Essential requirements
- Bachelor’s degree in Engineering, Data Science, Statistics, Quality Engineering, or a related technical field.
- 5+ years in quality engineering, quality systems, or post-market surveillance, with a strong focus on 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 Power BI dashboards and reports and using advanced data analysis tools.
- Proficiency with SQL, Excel, and statistical analysis software such as Minitab, JMP, R, or Python.
Travel and work environment
- The role is remote and requires ability to work in a remote office environment using standard computer equipment.
- Travel may be up to 5%, including occasional overnight travel.
- When visiting laboratory or manufacturing environments, the employee must follow applicable safety standards and use required PPE.
Preferred qualifications
- 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, or equivalent quality certification is a plus.
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