Sr QA Post Market Data Analyst

Regulatory Jobs; United States; Remote; USD 83,000 - 146,000; Full time

Benefits offered by this job

Bonus eligible

Job summary

Integrated DNA Technologies (IDT) is seeking a Senior Quality Engineer – Post Market Data Analyst to transform post‑market data into actionable insights. Remote within the United States, reporting to the Senior QA Manager, you will build BI dashboards, perform advanced analytics, and support regulatory submissions to enhance product quality and patient safety.

Key requirements include a Bachelor's in engineering or related field, 5+ years in quality engineering with data analytics, and

Qualifications

• 5+ years in quality engineering or post-market surveillance with data analytics focus.
• Knowledge of ISO 13485 and 21 CFR parts; medical device/IVD quality requirements.
• Experience building dashboards/reports with Power BI and advanced analytics.
• Proficiency in SQL, Excel, and statistical tools (Minitab/JMP/R/Python).

Responsibilities

• Develop, maintain, and automate Power BI dashboards for complaint trends and risk indicators.
• Apply advanced statistics to identify signals, recurring issues, and systemic risks.
• Generate trend reports for QMRs, CAPA, and regulatory submissions.
• Ensure data integrity and governance of complaint data via validation and reconciliation.
• Collaborate with QA, Regulatory, IT, and Manufacturing to drive CAPA actions.

Skills

Data analytics

Quality engineering

Statistical analysis

ISO regulatory knowledge

Education

Bachelor's degree in Engineering

Master's degree

Tools

Power BI

SQL

Excel

Minitab

JMP

R

Python

Job description

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:

• 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.

It would be a plus if you also possess previous experience in:

• Master's degree in Engineering, Data Science, Statistics, or a related discipline.
• Experience within regulated industries such as medical devices, biotechnology, pharmaceuticals, or aerospace.
• Six Sigma Green Belt, Black Belt, Certified Quality Engineer (CQE), or equivalent quality certification.

IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.

The 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.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real‑life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].