Staff Quality Assurance Scientist - Miami Florida

Company: Beckman Coulter Diagnostics
Location: Miami, Florida
Posted On: 01/18/2025

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges!The Staff Quality Assurance Scientist is a part of a dynamic quality compliance environment on the Quality Operations team and reports to the Senior Manager of Quality Assurance in Miami, FL. This will be an onsite role in Miami the individual will be a key team member in the Field Action (FA), Stop Shipment (SS), and Manufacturing Quality Operations teams. If you thrive in a fast-paced role and want to contribute to a world-class Quality organization that provides learning opportunities, this role is for you!In this role, you will have the opportunity to:

• Lead Product Escalation and Field Action activities for the Urinalysis and Hematology product lines.
• Lead Danaher Business Systems (DBS) activities such as Daily Management, Visual Project Management (VPM), and Kaizens.
• Foster partnerships with cross functional areas to support post market quality processes related to Field Action (FA), Stop Shipment (SS), and product escalation teams.
• Actively collaborate with cross-functional key stakeholders in support of post market quality activities.
• Strong understanding of a medical device quality management system. Working knowledge of the BEC quality systems and procedures a plus.The essential requirements of the job include:
  • Bachelor's degree with 9 years' experience, or a Master's degree with 7 years' in Science or Engineering with demonstrated experience in a highly regulated environment.
  • Experience with an area of post market compliance: complaints, CAPA, Field Action, quality systems, quality assurance or regulatory.
  • Capable solving complex problems with analytical data and a broad perspective, facilitating others involvement in identifying innovative solutions.
  • Demonstrated strong understanding of medical device (QMS) quality management system.
  • Proficient in Microsoft Word, Excel, and Power Point, Outlook. It would be a plus if you also possess previous experience in:
    • QMS training from ASQ, AAMI, or other accredited organization.
    • Oracle OBI experience.
    • Ability to communicate difficult concepts and negotiates with others to adopt a different point of view.
    • Leading others to solve complex problems; uses sophisticated analytical thought to exercise judgement and identify innovative solutions
    • Familiar with urinalysis and hematology equipmentDanaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation. More...

          

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