Staff Quality Assurance - In Vitro Diagnostics Risk Management in Miami, Florida at Beckman Coulter Diagnostics

Date Posted: 4/1/2018

Job Snapshot

Job Description

Job ID: BEC009138

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.


Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.

If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.


Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


Description

The ideal candidate will possess a comprehensive understanding of requirements and will have direct experience with the implementation of ISO standards for medical devices with emphasis on medical device risk management (EN ISO 14971:2012).  The position will cover QA risk management oversight for the Miami, Florida product lines: hematology, urinalysis, and flow Cytometry.



The Staff QA Risk Management Engineer 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. 



  • Act as a subject matter expert on risk management and provides support across the broader organization

  • Expertise in risk evaluation for post market issues for product safety and provides guidance on the completion of the risk documents

  • Approve all post launch risk assessments and facilitates the decision making process among stake holders

  • Exercise independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures

  • Collaborate and resolve conflicts independently

  • High degree of analysis and judgment

  • Effective communication, teamwork, and negotiation skills are required to work with personnel at all levels of the organization

Job Requirements



Qualifications


  • Bachelor’s Degree in Scientific or Engineering discipline with 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

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

  • Experience participating on cross functional teams

  • Ability to perform detail-oriented work with a high degree of accuracy

  • 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.