Quality Engineer - Post-Market & CAPA for Life Sciences

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

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.