Danaher Corporation Senior Quality Assurance Scientist - Field Actions 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.

Description
The Senior Quality Assurance (QA) Scientist for Field Actions (FA) is primarily responsible for support with the execution of strategies and operational initiatives developed by site leadership in the area of field actions (FA). The Senior QA Scientist provides primary support for Field Action activities by collaborating in the Field Action / Recall processes to ensure that voluntary or mandatory corrections, removals and recalls are managed effectively and efficiently and reported to regulatory agencies as required.

Job Description:

The Senior Quality Assurance (QA) Scientist for Field Actions (FA) is primarily responsible for support with the execution of strategies and operational initiatives developed by site leadership in the area of field actions (FA). The Senior QA Scientist provides primary support for Field Action activities by collaborating in the Field Action / Recall processes to ensure that voluntary or mandatory corrections, removals and recalls are managed effectively and efficiently and reported to regulatory agencies as required.

The roles and responsibilities of Senior QA Scientist (FA) include but is not limited to the following

  • Coordinate pre-field action activities for Watch list, FA Assessments and implementation of FA strategy. Participate in correction and recall strategies to include effectiveness checks, recall letters and recall reports
  • Participate and contribute to daily management activities pertaining to FAs
  • Obtain data and facts from subject matter experts for preparation of FA assessments, Agency reports and Agency inquiries as related to field actions
  • Pull customer lists and prepare and send out Customer Letter Mailings and customer email blasts
  • Maintain Master Tracking List for Field Actions, Progress Reports, and Agency Responses. Track and document customer responses and recall response rates. Track and communicate Regulatory Agency commitments and due dates
  • Maintain Field Action binders and FA supplemental binders and ensure that supported sites have access to these records at all times
  • Participate in audit preparedness to ensure accuracy and completeness of pertinent records and documentation. Assist in the coordination of document management for data analysis and data review processes for audit readiness
  • Maintain professional and technical knowledge and continually update job knowledge by interacting with “Subject Matter Experts”. Apply knowledge to develop and optimize processes, and suggest improvement to current processes as needed
  • Provide a high level of professional support during internal and external audits; Perform other related duties and assignments as required

Qualification

  • Bachelor’s degree in Science and 5 years of relevant Quality/Regulatory Affairs experience or Master’s degree in Science and 3 years of relevant Quality/Regulatory Affairs experience or doctoral degree in field with 0-2 years or relevant experience. Experience Desired
  • Experience managing multiple high priority projects at the same time
  • Demonstrated knowledge of BEC products (Hematology, Flow Cytometry, and Urinalysis)
  • FDA regulated environment experience is strongly recommended
  • Ability to drive results, foster teamwork, handle pressure, and provide feedback
  • Experience participating on cross functional teams
  • Knowledge of recall requirements in the US, Canada, EU and other international countries
  • Knowledge Quality and Regulatory requirements associated with recalls which include Risk Management, Complaints, Investigations, CAPAs, and Quality Notifications.Personal Skills / Attributes
  • Proven ability to work cross-functionally in a team based environment
  • Effective analytical and problem solving skills

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: Science
Primary Location: North America-North America-United States-FL-Miami
Schedule: Full-time
Req ID: BEC011185