Sr Quality Engineer - Post Market Data Analyst

Posted 6 Days Ago
Hiring Remotely in USA
Remote
66K-116K Annually
Senior level
Healthtech
The Role
Lead post-market complaint data analysis and dashboards to identify trends, support investigations and CAPA, ensure data governance, and enable regulatory compliance and continuous improvement across Quality and cross-functional teams.
Summary Generated by Built In

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 Opportunity

The Senior Quality Engineer – Data Analytics is responsible for transforming complaint and quality system data into actionable insights that drive product quality, patient safety, regulatory compliance, and continuous improvement. This full-time, permanent position combines quality engineering expertise with advanced analytics to support post-market surveillance activities, enable data-driven decision-making, and improve the effectiveness of IDT's Quality Management System. The role serves as a key business partner across Quality, Regulatory, and Operations organizations by providing meaningful trend analysis, business intelligence, and data governance support.

This position reports to the Manager, QA Complaints and is part of the Quality Assurance organization. This position is fully remote within the United States.

In this role, you will have the opportunity to:
  • Develop, maintain, and automate complaint analytics dashboards, reports, and statistical trend analyses to monitor quality performance, identify emerging signals, and support Quality Management Reviews, CAPA activities, and business decision-making.
  • Ensure the integrity, accuracy, and governance of complaint and quality system data through validation, reconciliation, audit trail management, and continuous improvement of reporting processes.
  • Provide data-driven support for complaint investigations, root cause analysis, risk management activities, and CAPA effectiveness evaluations to strengthen product quality and patient safety outcomes.
  • Collaborate with Quality Assurance, Regulatory Affairs, Scientific Application Support, Product Development, Manufacturing, Process Engineering, and other cross-functional stakeholders to identify trends and drive continuous improvement initiatives.
  • Support regulatory compliance, internal and external audits, and inspections through accurate reporting, analysis, documentation, and application of quality system requirements.
The essential requirements of the job include:
  • Bachelor's degree in Engineering, Data Science, Statistics, Computer Science, Quality, or a related technical discipline with 5+ years of relevant experience, OR a Master's degree in a related field with 3+ years of relevant experience
  • Experience developing and maintaining business intelligence and reporting solutions using Power BI, Tableau, or similar data visualization platforms.
  • Proficiency in statistical analysis and data management tools, including SQL and Microsoft Excel, with experience using Minitab, JMP, R, or Python.
  • Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, CAPA, complaint handling, risk management processes, and Quality Management System requirements.
It would be a plus if you also possess previous experience in:
  • Master's degree in Engineering, Data Science, Statistics, or a related technical field.
  • Medical device, in vitro diagnostics (IVD), biotechnology, or pharmaceutical industry experience.
  • ASQ Certified Quality Engineer (CQE) certification and/or experience supporting regulatory inspections and quality system audits.
Travel, Motor Vehicle Record & Physical/Environment Requirements
  • Ability to travel up to 10% for team meetings, training, audits, inspections, or business-related activities.
  • Ability to remain stationary and work at a computer for extended periods of time.
  • Ability to communicate effectively through virtual collaboration tools, video conferencing platforms, and presentations.
  • Ability to occasionally move materials and equipment associated with office and quality system activities.
Remote Work Arrangement

At IDT, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for IDT can provide.

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 66,000.00 - 115,500.00. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

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 [email protected].

Skills Required

  • Bachelor's degree in Engineering, Data Science, Statistics, Computer Science, Quality, or related field with 5+ years experience, OR Master's with 3+ years
  • Experience developing and maintaining business intelligence and reporting solutions using Power BI, Tableau, or similar platforms
  • Proficiency in statistical analysis and data management tools, including SQL and Microsoft Excel; experience with Minitab, JMP, R, or Python
  • Working knowledge of ISO 13485, 21 CFR Part 820, 21 CFR Part 803, CAPA, complaint handling, risk management processes, and QMS requirements
  • Master's degree in Engineering, Data Science, Statistics, or related technical field
  • Medical device, in vitro diagnostics (IVD), biotechnology, or pharmaceutical industry experience
  • ASQ Certified Quality Engineer (CQE) certification and/or experience supporting regulatory inspections and quality system audits

Danaher Corporation Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.

  • Healthcare Strength Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
  • Retirement Support Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
  • Parental & Family Support Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.

Danaher Corporation Insights

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The Company
HQ: Washington , DC
57,802 Employees
Year Founded: 1984

What We Do

Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.

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