Senior Quality Engineer

Posted 9 Days Ago
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Pensacola, FL
In-Office
Senior level
Healthtech
The Role
The Senior Quality Engineer ensures compliance with quality standards for membrane products and medical devices, while improving quality management systems and processes.
Summary Generated by Built In

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Senior Quality Engineer is responsible for ensuring the quality of membrane products and medical devices by facilitating cross-functional execution of the Quality Management System (QMS), setting inspection processes, implementing quality control measures, and identifying statistical trends. This role ensures compliance with ISO 13485, and ISO 9001 standards, addresses customer complaints, resolves production quality issues, and supports new product introduction projects. Additionally, the Senior Quality Engineer drives continuous improvement, and collaborates with R&D, manufacturing, and regulatory teams to maintain product safety and regulatory compliance.

This position reports to the Senior Manager, Site Quality and is part of the Quality Engineering group located in Pensacola and will be an on-site role.    

What you will do:

  • Lead root cause analysis and implement CAPA for nonconformities using the risk management processes.
  • Ensure design control process compliance throughout the product lifecycle and deliver training on quality processes.
  • Establish, monitor, and analyze QMS process performance; lead quality improvement projects.
  • Review and approve deviations, document changes, validation activities, and change controls.
  • Drive process improvements using Lean/Six Sigma methodologies.

Who you are:

  • Bachelor’s degree in Engineering or related Science field.
  • 7+ years in medical device quality engineering.
  • Strong knowledge of ISO 13485, FDA QSR, ISO 9001, and risk management tools.

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our 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 Danaher Benefits Info.

#LI-LCS

    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 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.

    The U.S. EEO posters are available here.

    We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].

    Top Skills

    Fda Qsr
    Iso 13485
    Iso 9001
    Lean
    Six Sigma
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    The Company
    Washington , DC
    57,802 Employees

    What We Do

    Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.

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