Senior Quality Engineer (Sunday-Thursday)

Posted 5 Days Ago
Be an Early Applicant
Pensacola, FL, USA
In-Office
Senior level
Healthtech
The Role
Ensure membrane products and medical devices meet quality and regulatory standards by executing QMS processes, leading root-cause investigations, implementing process validation and control (IQ/OQ/PQ, SPC), applying risk-based tools (PFMEA, ISO 14971), resolving production/customer quality issues, and supporting continuous improvement and new product introductions.
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. This role is for working days of Sunday to Thursday.   

What you will do:

  • Provided strategic quality oversight for manufacturing operations, ensuring compliance with applicable regulatory standards while driving a culture of quality excellence across production teams.
  • Led complex root cause investigations and remediation efforts using tools such as 8D, DMAIC, and fishbone analysis, implementing robust corrective and preventive actions to eliminate recurring issues.
  • Directed process validation and control strategies (IQ/OQ/PQ, SPC), improving process capability, reducing variability, and maintaining consistent product quality in high-volume manufacturing environments.
  • Applied risk-based approaches (PFMEA, control plans, ISO 14971 principles) to proactively identify and mitigate process risks, ensuring product safety, reliability, and compliance.
  • Collaborated cross-functionally with engineering, operations, and suppliers to drive continuous improvement initiatives, optimize manufacturing processes, and support successful product transfers and launches.

Who you are:

  • Bachelor’s degree in Engineering or related Science field.
  • 5+ years experience in quality engineering in a regulated environment
  • Preferred experience in high volume manufacturing environments, using lean principals
  • Preferred green belt and/or CQE
  • Strong knowledge of either ISO 9001/13485/16949, FDA QSR, 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. 

  

This job is also eligible for bonus/incentive pay. 

  

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 

 

#LI-TC2

    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.


    For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click 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].

    Skills Required

    • Bachelor's degree in Engineering or related Science field
    • 5+ years experience in quality engineering in a regulated environment
    • Strong knowledge of ISO 9001, ISO 13485, ISO 16949, and FDA QSR
    • Experience leading root cause investigations using 8D, DMAIC, and fishbone analysis
    • Experience with process validation and control strategies (IQ/OQ/PQ, SPC)
    • Experience with risk-based approaches (PFMEA, control plans, ISO 14971 principles)
    • Preferred experience in high-volume manufacturing using lean principles
    • Preferred Green Belt certification and/or Certified Quality Engineer (CQE)

    Danaher Corporation Compensation & Benefits Highlights

    The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.

    • Healthcare Strength Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
    • Retirement Support Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
    • Parental & Family Support Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.

    Danaher Corporation Insights

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    The Company
    HQ: Washington , DC
    57,802 Employees
    Year Founded: 1984

    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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