Quality Engineer (IVD)

Location: On-site in Coralville, Iowa, United States

Company

hirify.global is a life sciences, diagnostics, and biotechnology organization whose operating company Integrated DNA Technologies develops oligonucleotide products and genomics solutions.

What you will do

• 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 for audits, inspections, and regulatory compliance.
• Support post-market surveillance, complaint trending, risk identification, and regulatory reporting.
• Collaborate with Manufacturing, Quality Control, Regulatory Affairs, and R&D on quality trends, process performance, and continuous improvement.
• Initiate and support CAPA activities resulting from complaint investigations.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a 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 with structured root cause investigation methods, including 5-Why Analysis, Fishbone Diagrams, DMAIC, or similar tools.
• Experience using data analysis tools and quality systems for investigations, complaint management, and continuous improvement.
• Ability to travel up to 5%, work around chemicals and laboratory materials, use required personal protective equipment, and occasionally lift up to 10 pounds.

Nice to have

• Experience in medical device, pharmaceutical, biotechnology, or IVD industries.
• Advanced degree in a scientific or engineering discipline.
• Six Sigma Green Belt, Black Belt, Certified Quality Engineer, or similar certification.

Culture & Benefits

• Culture focused on belonging, collaboration, scientific excellence, continuous learning, and continuous improvement.
• Opportunity to contribute to genomics, diagnostics, and life sciences products with real-world health impact.
• Work in a primarily sedentary environment with occasional physical activity and required laboratory safety equipment.