Job Information
Danaher Corporation Quality Assurance Engineer II in Miami, Florida
Wondering what’s within Beckman Coulter?
Take a closer look.
Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, we’re building a culture that celebrates culture, experiences, and perspectives of all our associates. At first glance, you’ll see we are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Look again and you’ll see we are invested in you and you’ll have the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. You’ll find the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) , which makes everything possible. You’ll also see a company that investors trust—our culture of continuous improvement has helped us outperform the S&P 500 by more than 5,000% over the past 25 years.
And no matter where you look at Beckman Coulter, at the heart of what we do, you’ll witness our shared purpose—helping realize life’s potential—in action. Our work helps improve millions of lives.
We hope you’ll see yourself here, too.
What you find at Beckman Coulter —and within yourself — might just change the world!
The Quality Assurance Engineer for Beckman Coulter Diagnostics is responsible for completing Process validation deliverables for Diagnostics, Life Science and Urine Analysis Business units. It will also ensure integrity of products manufactured and shipped out to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards.
This position is part of the Miami Process Validation Group and will be located in Miami/Hialeah traveling between sites. Miami PV Specializes in all types of validation deliverables, maintaining an environment of impeccable compliance affording a competitive advantage to our partners.
The engineer is part of the Miami PV and reports to the Senior Manager, Process Validation. They will work with senior QA staff and be responsible on instrument manufacturing responsible for Process Validation & QA Instrument Shared services. If you thrive in a constantly changing, multitasking-role and want to work to build a world-class Process Validation / Instrument QA organization—read on.
In this role, you will have the opportunity to:
Write and conduct IOQ, and spreadsheet validations.
Complete PQ, TMV, AQ as well as NPSV validations
May manage process and product non-conformances in line with company procedures
Develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.
The essential requirements of the job include:
Bachelor’s degree in Engineering: mechanical, electrical, chemical, bioengineering or related area and 2+ years of experience in medical device industry
Familiarity with CFR 21 part 820, ISO13485
Proficient in Microsoft Excel and good working knowledge of computer programming and systems
It would be a plus if you also possess previous experience in:
Knowledge of PQ, TMV, AQ, NPSV validations
Exposure to Gamp5 or similar regulations
ASQ Certified Quality Engineer (CQE) is a plus
Beckman Coulter, a Danaher company, 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 at danaherbenefitsinfo.com. We believe you’ll like what you see.
At Beckman Coulter, we’re driven by a sense of wonder for what we can create—and what we can become. Here, you’ll accelerate your career while driving innovation that improves lives. You’ll work hard and try new things, with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of the Danaher family of 67,000 associates across the globe, your possibilities for growth and development are unparalleled.
We believe that creativity and innovation thrive when the most diverse set of voices are heard, and that’s why we’re taking concrete steps to ensure that we’re fostering an inclusive and engaging workplace for our team. If you’d like to learn more, read stories from our associates on our Careers Blog (https://jobs.danaher.com/global/en/blog) or contact one of our recruiters.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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 (https://www.dol.gov/agencies/ofccp/posters) .
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 applyassistance@danaher.com to request accommodation.