Sr Quality Assurance Scientist - Complaint Handling in Miami, Florida at Beckman Coulter Diagnostics

Date Posted: 3/14/2018

Job Snapshot

Job Description

Job ID: BEC009377

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.


The Senior Quality Assurance 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. 


  • Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by the company in a manner consistent with all laws and regulations for medical devices.

  • Generate and analyze customer feedback (CF) data to improve product reliability and performance for our customers.

  • Assess complaint information for determination of adverse event reporting and/or vigilance reporting.

  • Possess understanding of risk management concepts and is capable of assessing product risks across unit of work.

  • Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities.

  • Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements.

  • Oversight of critical Post Market projects and routinely share project goals, status, requirements, and deliverables to upper management. Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Engineering, Service/Support, Sales, Research and Development, Quality, Regulatory and Marketing. Ensure completion of key deliverables.

Job Requirements



  • Bachelor’s degree with 5+ years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience

  • Master’s degree with 3+ years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience 

  • Medical Technologist /Clinical Laboratory background preferred

Experience desired:

  • Knowledge of domestic and international quality systems and other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations.

  • Ability to drive results, foster teamwork, handle pressure, and provide feedback

  • Experience leading cross functional teams

  • 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.