Quality Engineer — Post-Market & CAPA Leader

Radiometer; Coralville (IA); On-site; USD 70,000 - 90,000; Full time

Job summary

IDT, a Danaher company, seeks a Quality Engineer to manage customer complaints on oligonucleotide products, driving post-market surveillance and CAPA initiatives. You will partner with Manufacturing, QC, Regulatory Affairs and R&D to analyze trends and support regulatory compliance, reporting findings to the QA Manager of Complaints.

The role is on-site in Coralville, IA, with responsibilities spanning investigations, data analysis, and continuous quality improvement, requiring a Bachelor’s

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).
• Working knowledge of ISO 13485, 21 CFR 820, 21 CFR 803, QSR, and IVD products.
• Experience conducting structured root cause investigations using methodologies such as 5-Why, Fishbone, DMAIC, or similar tools.
• Experience using data analysis tools and quality systems to support investigations and continual improvement.

Responsibilities

• Investigate customer complaints by reviewing manufacturing records, data, and product history to determine root cause and impact.
• Prepare summaries, communications, and documentation to support audits and regulatory activities.
• Support post-market surveillance, complaint trending, risk identification, and regulatory reporting.
• Collaborate with Manufacturing, Quality Control, Regulatory Affairs, and R&D to identify improvement opportunities.
• Initiate and support CAPAs stemming from investigations to improve product quality and process effectiveness.

Skills

Root cause investigations

CAPA

Data analysis

Quality systems

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/ Biochemistry/ Engineering

Job description

IDT, a Danaher company, seeks a Quality Engineer to manage customer complaints on oligonucleotide products, driving post-market surveillance and CAPA initiatives. You will partner with Manufacturing, QC, Regulatory Affairs and R&D to analyze trends and support regulatory compliance, reporting findings to the QA Manager of Complaints.

The role is on-site in Coralville, IA, with responsibilities spanning investigations, data analysis, and continuous quality improvement, requiring a Bachelor’s