Senior Quality Engineer (Sunday-Thursday)

Cytiva; Pensacola (FL); On-site; USD 85,000 - 120,000; Full time

Job summary

Cytiva in Pensacola, FL is seeking a Senior Quality Engineer to lead quality initiatives for membrane products and medical devices, ensuring QMS compliance and driving continuous improvement. This on-site role reports to the Site Quality Senior Manager and supports new product introductions.

The incumbent will collaborate with R&D, manufacturing, and regulatory teams to maintain product safety and regulatory compliance while applying ISO 9001/13485 standards and risk management tools.

Qualifications

• 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 principles.
• Preferred green belt and/or CQE.
• Strong knowledge of ISO 9001/13485/16949, FDA QSR, and risk management tools.

Responsibilities

• Provide strategic quality oversight for manufacturing operations, ensuring regulatory standards compliance across production teams.
• Led complex root cause investigations using 8D, DMAIC, and fishbone analysis with robust corrective and preventive actions.
• Directed process validation and control strategies (IQ/OQ/PQ, SPC) to improve process capability and reduce variability.
• Applied risk-based PFMEA and ISO 14971 principles to identify and mitigate process risks.
• Collaborated with engineering, operations, and suppliers to drive continuous improvement and support product transfers and launches.

Skills

Quality engineering

Root cause analysis

DMAIC

8D

Risk management

Cross-functional collaboration

Process improvement

Education

Bachelor's degree in Engineering or related Science field

Tools

IQ/OQ/PQ

SPC

PFMEA

Job description

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.

Senior Quality Engineer

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.

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 us.