Senior Quality Investigator, Complaints & CAPA (On-Site)

Danaher Corporation; Coralville (IA); On-site; USD 70,000 - 95,000; Full time

Job summary

Integrated DNA Technologies (IDT) in Coralville, IA, is seeking a Senior Quality Investigator to manage and investigate customer complaints related to oligonucleotide products, ensuring compliant, timely resolution and post-market surveillance.

The role reports to the QA Manager of Complaints within the Quality Assurance organization and is an on-site position in Coralville, Iowa. Occasional travel may be required and cross-functional collaboration is essential.

Qualifications

• Bachelor’s in Chemistry, Biochemistry, Engineering or related science.
• 2+ years QA experience in regulated/ISO environments.
• Familiarity with ISO 13485, 21 CFR 820/803, QSR and IVD.
• Experience with root-cause investigations (5-Why, Fishbone, DMAIC).
• Experience using data analysis tools for investigations.

Responsibilities

• Investigate customer complaints and determine root cause.
• Prepare investigation summaries and communications for audits.
• Support post-market surveillance and regulatory reporting.
• Collaborate with Manufacturing, QC, Regulatory Affairs, R&D on improvements.
• Initiate and support CAPAs to improve quality and process.

Skills

Root cause analysis

DMAIC

5-Why Analysis

Fishbone Diagrams

Data analysis

Quality systems

Regulatory compliance

Education

Bachelor's degree in Chemistry, Biochemistry, Engineering, or related science

Tools

ISO 13485

21 CFR 820

QSR

Quality management software

Job description

Integrated DNA Technologies (IDT) in Coralville, IA, is seeking a Senior Quality Investigator to manage and investigate customer complaints related to oligonucleotide products, ensuring compliant, timely resolution and post-market surveillance.

The role reports to the QA Manager of Complaints within the Quality Assurance organization and is an on-site position in Coralville, Iowa. Occasional travel may be required and cross-functional collaboration is essential.