[Hiring] Senior Quality Engineer - Post Market Data Analyst @Danaher Corporation

Role Description

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. This role serves as a key quality engineering and analytics resource, developing business intelligence solutions, identifying emerging quality trends, and enabling data-driven decision making across the organization.

This position reports to the Sr. Quality Assurance Manager and is part of the Quality Assurance/Regulatory Affairs organization, located remotely within the United States and will be fully remote.

In this role, you will have the opportunity to:

• 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 Quality Management Reviews (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.

Qualifications

• 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.

Requirements

• 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.
• Must be able to comply with all applicable safety standards and procedures, including the use of required PPE when visiting laboratory or manufacturing environments.

Benefits

• Comprehensive, competitive benefit programs including health care programs and paid time off.
• Remote work arrangement eligible for this position.
• Annual salary range of $83,000.00 - $145,500.00.
• Eligible for bonus/incentive pay.
• Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.