Quality Engineer

Socket.dev; Coralville (IA); On-site; USD 70,000 - 90,000; Full time

Job summary

Integrated DNA Technologies (IDT) in Coralville, IA, is seeking a Quality Engineer to manage and investigate customer complaints tied to oligonucleotide products. The role drives product quality improvements through CAPA and post-market surveillance within the Quality Assurance organization.

The position reports to the QA Manager of Complaints and requires 2+ years in quality engineering within regulated environments. On-site role based in Coralville, Iowa.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Engineering, or another related scientific discipline.
• 2+ years of Quality Engineering experience in a regulated environment (ISO 9001 or ISO 13485).
• Experience with ISO 13485, 21 CFR 820/803, QSR, and IVD products.

Responsibilities

• 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 and regulatory compliance.
• Support post-market surveillance activities including complaint trending, risk identification, and regulatory reporting requirements.
• Partner with Manufacturing, Quality Control, Regulatory Affairs, and R&D to identify opportunities for continuous improvement.

Skills

Root cause analysis

CAPA processes

Data analysis

Regulatory compliance

Education

Bachelor's degree in Chemistry, Biochemistry, Engineering, or related science

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 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.

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For more information, visit www.danaher.com.

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