Quality Engineer, Life Sciences & CAPA Excellence

Integrated DNA Technologies; Coralville (IA); On-site; USD 70,000 - 100,000; Full time

Job summary

Integrated DNA Technologies (IDT) seeks a Quality Engineer to manage and investigate customer complaints on oligonucleotide products, ensuring timely, compliant resolutions. You will drive post-market surveillance, root cause investigations, CAPA activities, and cross-functional collaboration to support regulatory compliance and customer satisfaction.

This on-site role in Coralville, IA reports to the QA Manager of Complaints within the Quality Assurance organization and requires a strong

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Engineering, or related science required.
• 2+ years of Quality Engineering experience in regulated environments.
• Working knowledge of ISO 13485, 21 CFR 820/803, QSR, and IVD products.
• Experience with structured root cause investigations and quality tools.
• Experience using data analysis tools to support investigations and improvements.

Responsibilities

• Investigate customer complaints by reviewing records and data to determine root cause and impact.
• Prepare summaries and communications to support audits, inspections, and regulatory activities.
• Coordinate post-market surveillance, complaint trending, and risk identification.
• Collaborate with Manufacturing, Quality Control, Regulatory Affairs and R&D on improvements.
• Initiate and support CAPAs to improve product quality and process effectiveness.

Skills

Quality engineering

Root cause analysis

Data analysis

Regulatory knowledge

ISO 13485

QSR knowledge

Education

Bachelor's degree in Chemistry, Biochemistry, Engineering, or related scientific discipline

Tools

5-Why Analysis

DMAIC

Fishbone Diagram

Statistical analysis

Job description

Integrated DNA Technologies (IDT) seeks a Quality Engineer to manage and investigate customer complaints on oligonucleotide products, ensuring timely, compliant resolutions. You will drive post-market surveillance, root cause investigations, CAPA activities, and cross-functional collaboration to support regulatory compliance and customer satisfaction.

This on-site role in Coralville, IA reports to the QA Manager of Complaints within the Quality Assurance organization and requires a strong