QA Complaint Analyst
Coralville, IA - USA
Job Summary
At Integrated DNA Technologies (IDT) one of Danahers operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.
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:
Bachelors 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 ISOCFR 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 its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.
For more information visit .
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.
For candidates who are based outside of New York City or who are applying for roles outside of New York City for more information about conditions of any job offer please click 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- or .
Required Experience:
IC
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more