Role Overview
The Senior Quality Engineer – Post Market Data Analyst is responsible for transforming post-market surveillance and complaint handling data into actionable insights that drive product quality, patient safety, regulatory compliance, and continuous improvement.
What You Will Do
Develop, maintain, and automate Power BI dashboards and reports, perform advanced statistical analyses, generate and communicate trend reports, and ensure integrity, accuracy, and governance of complaint data.
Why It Might Be a Fit
This role requires a strong focus on data analytics and reporting, with experience in quality engineering, quality systems, or post-market surveillance. The ideal candidate will have a working knowledge of ISO 13485, 21 CFR Part 820, and medical device or IVD quality requirements.
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 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
Benefits
- Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k)
- Bonus/incentive pay
- Flexible, remote working arrangements
To apply for this job please visit danaher.wd1.myworkdayjobs.com.
Follow us on social media