Quality Engineer: Complaints & CAPA for Life Sciences

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

Job summary

Danaher Corporation, including its IDT operation in Coralville, Iowa, is seeking a Quality Engineer to manage and investigate customer complaints related to oligonucleotide products. The role emphasizes regulatory compliance, post-market surveillance, CAPA activities, and cross-functional collaboration to improve product quality.

The position is on-site in Coralville, IA, with travel up to 5%, and requires a Bachelor’s degree in a related science and 2+ years of experience in a regulated quality

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, or related scientific field.
• 2+ years of Quality Engineering experience in regulated environments (ISO 9001/ISO 13485).
• Knowledge of ISO 13485, 21 CFR 820/803, QSR, and IVD products.
• Experience with structured root-cause investigations (5-Why, Fishbone, DMAIC).
• Experience using data analysis tools and quality systems for investigations and continuous improvement.

Responsibilities

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

Skills

Root cause analysis

Quality systems

Data analysis

Investigations

Education

Bachelor’s degree in Chemistry, Biochemistry, Engineering, or related scientific field

Job description

Danaher Corporation, including its IDT operation in Coralville, Iowa, is seeking a Quality Engineer to manage and investigate customer complaints related to oligonucleotide products. The role emphasizes regulatory compliance, post-market surveillance, CAPA activities, and cross-functional collaboration to improve product quality.

The position is on-site in Coralville, IA, with travel up to 5%, and requires a Bachelor’s degree in a related science and 2+ years of experience in a regulated quality