Quality Engineer

Posted 3 Days Ago
Be an Early Applicant
Coralville, IA, USA
In-Office
Junior
Healthtech
The Role
Investigates customer complaints involving oligonucleotide products, determines root causes and product impact, prepares investigation and regulatory documentation, supports post-market surveillance and complaint trending, and initiates CAPA activities. Collaborates with Manufacturing, Quality Control, Regulatory Affairs, and R&D to improve product quality, process performance, and compliance.
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 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 Quality Engineer is responsible for managing and investigating customer complaints associated with oligonucleotide products while ensuring compliant, timely, and effective resolution processes. This role drives product quality improvements through post-market surveillance, root cause investigations, CAPA activities, and cross-functional collaboration to support regulatory compliance and customer satisfaction.

This position reports to the QA Manager of Complaints and is part of the Quality Assurance organization located in Coralville, Iowa and will be an on-site role.

In this role, you will have the opportunity to:
  • Investigate customer complaints by reviewing manufacturing records, analytical data, and product history to determine root cause and product impact.  
  • Prepare investigation summaries, customer communications, and documentation to support audits, inspections, and regulatory compliance activities
  • Support post-market surveillance activities, including complaint trending, risk identification, and regulatory reporting requirements.
  • Partner with Manufacturing, Quality Control, Regulatory Affairs, and R&D teams to identify opportunities for continuous improvement through analysis of complaint data, quality trends, and process performance.
  • Initiate and support CAPAs resulting from complaint investigations to improve product quality and process effectiveness.
The essential requirements of the job include:
  • Bachelor's degree in Chemistry, Biochemistry, Engineering, or another related scientific discipline.
  • 2+ years of Quality Engineering experience in a regulated or standardized environment such as ISO 9001 or ISO 13485.
  • Working knowledge of ISO 13485, 21 CFR 820, 21 CFR 803, Quality System Regulations (QSR), and IVD products.
  • Experience conducting structured root cause investigations using methodologies such as 5-Why Analysis, Fishbone Diagrams, DMAIC, or similar problem-solving tools.
  • Experience utilizing data analysis tools and quality systems to support investigations, complaint management, and continuous improvement activities.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
  • Ability to travel up to 5%, including occasional overnight travel.
  • Ability to work around chemicals and laboratory-related materials.
  • Ability to wear required personal protective equipment, including gloves and safety glasses and perform work in a primarily sedentary environment with occasional lifting of up to 10 pounds.
It would be a plus if you also possess previous experience in:
  • Medical device, pharmaceutical, biotechnology, or in vitro diagnostic (IVD) regulated industries.
  • Advanced degree in a scientific or engineering discipline.
  • Six Sigma Green Belt, Black Belt, Certified Quality Engineer (CQE), or similar quality certification.

#LI-LCS

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 Chemistry, Biochemistry, Engineering, or another related scientific discipline
  • At least 2 years of Quality Engineering experience in a regulated or standardized environment such as ISO 9001 or ISO 13485
  • Working knowledge of ISO 13485, 21 CFR 820, 21 CFR 803, Quality System Regulations, and IVD products
  • Experience conducting structured root cause investigations using 5-Why Analysis, Fishbone Diagrams, DMAIC, or similar methods
  • Experience using data analysis tools and quality systems for investigations, complaint management, and continuous improvement
  • Experience in medical device, pharmaceutical, biotechnology, or IVD regulated industries
  • Advanced degree in a scientific or engineering discipline
  • Six Sigma Green Belt, Black Belt, Certified Quality Engineer, or similar quality certification

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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