Danaher Corporation Staff Quality Assurance Risk Management - Med Device in Miami, Florida
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 Staff QA Risk Management will possess a thorough understanding of the requirements and has direct experience with the implementation of ISO standards for medical devices with emphasis on medical device risk management (EN ISO 14971:2012).
The QA specialist provides oversight on the implementation of the Beckman Coulter product safety risk management process for new product development projects, design changes, and facilitates risk management activities in compliance with Beckman Coulter procedures. The incumbent is responsible for teaching, coaching, and mentoring team members on risk management and approving all risk management deliverables. The risk specialist acts as a subject matter expert on risk management and provides support across the broader organization.
The incumbent in this roll will act as the expert in risk evaluation for post market issues for product safety and provides guidance on the completion of the risk documents. The risk specialist approves all post launch risk assessments and facilitates the decision making process among the stake holders.
The QA risk specialist exercises independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures. Possesses excellent collaboration skills and can resolve conflicts independently. Possesses a high degree of analysis and judgment. Effective communication, teamwork, and negotiation skills are required to work with personnel at all levels of the organization.
The position will cover QA risk management oversight for the Miami, Florida product lines: hematology, urinalysis, and flow cytometry.
- Bachelor’s Degree in Scientific or Engineering discipline
- 10 years' medical device experience, Master’s Degree with 8 years' medical device experience, or Ph.D. with 6 years' medical device experience
- Experience with risk management for medical devices is desirable
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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-FL-Miami
Req ID: BEC011183