QA Complaint Analyst

Radiometer

Coralville (IA)

On-site

USD 48,000 - 68,000

Full time

9 days ago
Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Integrated DNA Technologies (IDT) in Coralville, IA is seeking a Complaint Analyst to help ensure product safety and regulatory compliance through effective management of customer complaints and post-market surveillance.

You will work with cross-functional teams to investigate issues, document results, and drive CAPAs, SCARs, and other quality system activities to improve customer satisfaction and product performance. This is an on-site role reporting to the QA Manager, Complaints.

Qualifications

  • Bachelor's degree in Biological Sciences or a related field.
  • 1+ years of post-market product surveillance and complaint handling.
  • Experience conducting investigations within a regulated quality system.
  • Experience working with cross-functional teams to resolve product quality issues.
  • Experience maintaining quality records and supporting quality system processes.

Responsibilities

  • Contribute to the continuous improvement of product safety and compliance by effectively managing and resolving quality complaints.
  • Communicate with internal team members and external customers to facilitate complaint investigation process.
  • Receive and document complaints from customers, healthcare professionals, and internal stakeholders.
  • Work closely with cross‑functional teams (SAS, QA, Regulatory Affairs, Product Development, Manufacturing) to investigate and resolve complaints.
  • Support quality system investigations, including issue reviews, nonconformances, CAPAs, SCARs, as needed.

Skills

Data analysis
Cross-functional collaboration
Investigation

Education

Bachelor's degree in Biological Sciences or related field

Tools

SAP
Microsoft Office

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Integrated DNA Technologies (IDT), one of Danaher's operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Our team at Integrated DNA Technologies (IDT) is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life‑changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you'll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all. Learn about the Danaher Business System which makes everything possible.

The Complaint Analyst is responsible for supporting product quality, safety, and regulatory compliance through effective management of customer complaints and post‑market surveillance activities. This role partners with cross‑functional teams to investigate product‑related issues, support quality system processes, identify root causes, and drive continuous improvement efforts that enhance customer satisfaction and product performance. This position reports to the Quality Assurance Manager, Complaints and is part of the Quality Assurance Department located in Coralville, IA and will be an on‑site role.

In this role, you will have the opportunity to:
  • Contribute to the continuous improvement of product safety +compliance by effectively managing and resolving quality complaints
  • Communicate with internal team members and external customers to facilitate complaint investigation process.
  • Receive and document complaints from various sources, including customers, healthcare professionals, and internal stakeholders.
  • Work closely with cross‑functional teams, including Scientific Application Support (SAS), Quality Assurance, Regulatory Affairs, Product Development, and Manufacturing to investigate and resolve complaints.
  • Support quality system investigations, including issue reviews, nonconformances, CAPAs, SCARs, as needed.
The essential requirements of the job include:
  • Bachelor's degree in Biological Sciences or a related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry).
  • 1+ years of related experience in post‑market product surveillance and complaint handling.
  • Experience conducting investigations and documenting results within a regulated quality system environment.
  • Experience working with cross‑functional teams to resolve product quality issues.
  • Experience maintaining quality records and supporting quality system processes.
It would be a plus if you also possess previous experience in:
  • Proficiency in data analysis and workflow troubleshooting, including instrumentation, arrays, and biological materials.
  • Experience with SAP and proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint, or equivalent software applications.
  • Familiarity with ISO 13485, 21 CFR Part 820, 21 CFR Part 803, Quality System Regulation (QSR) requirements, and in vitro diagnostic (IVD) products.

IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.

Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

QA Complaint Analyst
QA Complaint Analyst

Socket.dev • Coralville (IA)

On-site
USD 60,000 - 85,000
Quality Engineer
Quality Engineer

Socket.dev • Coralville (IA)

On-site
USD 70,000 - 90,000
Custom Quality Analyst II (IDT Weekday 5 Days - Mid-day)
Custom Quality Analyst II (IDT Weekday 5 Days - Mid-day)

Integrated DNA Technologies • Coralville (IA)

On-site
USD 52,000 - 75,000
Quality Engineer (Complaint Handling) - Duncan, SC
Quality Engineer (Complaint Handling) - Duncan, SC

Cytiva • Duncan (SC)

On-site
USD 70,000 - 90,000
Bonus eligibility
Quality Engineer
Quality Engineer

Radiometer • Kentucky

On-site
USD 90,000 - 130,000
Medical/dental/vision insurance
401(k)
Paid time off
+1
On-Site QA Complaint Analyst — Drive Product Safety & Quality
On-Site QA Complaint Analyst — Drive Product Safety & Quality

Socket.dev • Coralville (IA)

On-site
USD 60,000 - 85,000
Technician II - Commercial and Regulated Products - Mon - Thurs 9:00am - 8:00pm
Technician II - Commercial and Regulated Products - Mon - Thurs 9:00am - 8:00pm

Danaher Corporation • Coralville (IA)

On-site
USD 42,000 - 62,000
Health insurance
401(k) plan
Technician II - Commercial and Regulated - Monday-Thursday, 9:00pm - 7:30am
Technician II - Commercial and Regulated - Monday-Thursday, 9:00pm - 7:30am

Danaher Corporation • Coralville (IA)

On-site
USD 45,000 - 60,000
Bonus potential
Comprehensive benefits
Quality Complaint Analyst (On-Site, Coralville IA)
Quality Complaint Analyst (On-Site, Coralville IA)

Radiometer • Coralville (IA)

On-site
USD 48,000 - 68,000
Sr. Microbiology Quality Engineer
Sr. Microbiology Quality Engineer

Cytiva • Hauppauge (NY)

On-site
USD 80,000 - 100,000