Danaher Corporation Quality Assurance Scientist - Complaint Handling in Chaska, Minnesota
Danaher Company Description
At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.
We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.
Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences.
The QA Scientist, on the Post Market team, will participate in complaint handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience.
- Review, evaluate and accept complaints to ensure the information is sufficient for a complete investigation
- Verify the initial complaint classification is correct
- Review complaints in accordance with established company procedures and worldwide regulations and standards
- Contact by email or direct phone call external customers, complaint originators, or Field Service Engineers to obtain all the necessary information to investigate fully
- Exercise judgment within defined procedures and practices to determine appropriate action
- Perform simple complaint investigation into alleged product performance complaints
- Communicate within a global environment to efficiently obtain the minimal information required from the complaint originator in a timely manner
- Summarize and document troubleshooting and investigational activities
* Bachelor´s degree with 0-2 years’ experience in Technical Field (Science or Engineering) and/or Compliance (Complaints, Quality/Regulatory) * Medical Technology/clinical laboratory background preferred * Excellent writing and organizational skills. Good computer skills to include Outlook email and other Microsoft applications such as Word, Excel and Power Point * Excellent communication skills to ensure that complaint documentation is clear and concise * Knowledge of Oracle database application desired * Heavy multi-tasking and organizational skills required * Work may be independent/flexible, so an ability to manage time and productivity to meet department metrics and a high level of personal integrity is required * Experience in Complaint Investigation or Post Market Surveillance/QA preferred * Knowledge of Immunoassay product lines. Excellent systems knowledge (instrument hardware as well as reagents) is highly desired * Basic knowledge of statistics/quality control desired
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Beckman Coulter - Diagnostics
Job Function: Science
Primary Location: North America-North America-United States-MN-Chaska
Req ID: BEC010758