Senior Quality Engineer

Cytiva; Pensacola (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

Health coverage

Paid time off

Job summary

Cytiva in Pensacola is seeking a Senior Quality Engineer to ensure membrane products and medical devices meet ISO 13485 and ISO 9001, by leading cross-functional execution of the QMS, setting inspection processes, and guiding CAPA.

You will work with R&D, manufacturing, and regulatory teams, drive continuous improvement, review deviations, and support new product introductions on-site at the Pensacola site.

Qualifications

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

Responsibilities

• Lead root cause analysis and implement CAPA for nonconformities using risk management processes.
• Ensure design control 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.

Skills

Root cause analysis

CAPA implementation

Design control

QMS

Lean Six Sigma

Risk management

Regulatory compliance

Education

Bachelor's degree in Engineering or related Science field

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 Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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:

• Bachelors 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 its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

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For more information, visit www.danaher.com.

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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 [e-mail].