Quality Engineer

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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 Danahers operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll be part of a culture rooted in continuous learning and improvementwhere your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier brighter future for all.

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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.

• 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.

• Bachelors 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 ISOCFR 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.

• 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.

• 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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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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