Sr QA Post Market Data Analyst
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职位描述
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Integrated DNA Technologies (IDT), one of Danaher ’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher ’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you’ll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all. Learn about the Danaher Business System which makes everything possible. 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. The essential requirements of the job include : (NOTE For Hiring Manager: Please reference the 3-5-7 Job Requirements Model ) · 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. Travel, Motor Vehicle Record Physical/Environment Requirements: if applicable for role · 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. undefined It would be a plus if
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