About this QA Complaint Analyst role at Danaher
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.
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. Check out our benefits at Danaher Benefits Info.
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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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 www.danaher.com.
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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 [email protected].
