Quality Engineer

Danaher; Logan (AL); On-site; USD 85,000 - 110,000; Full time

Job summary

Cytiva, a Danaher operating company, is hiring a Quality Engineer to provide QA support for biomanufacturing, ensuring compliance with regulatory requirements and quality standards. You will lead investigations, analyze data for CAPA, and partner across Manufacturing, R&D, and Quality to improve processes.

Based in Logan, Utah, this on-site role emphasizes audits, CAPAs, and continuous improvement within a GMP environment.

Qualifications

• Education & Experience: 5+ years in a GMP-regulated environment such as biopharmaceutical, biotech, medical device, or pharma manufacturing; 3+ years supporting investigations, CAPAs, quality systems.
• Technical & Regulatory Expertise: Knowledge of cGMP, ISO 9001/13485, audit readiness, documentation practices, and QMS improvements.
• Communication & Problem Solving: Ability to manage multiple priorities, strong technical writing, data analysis, and cross-functional collaboration.

Responsibilities

• Lead Quality Investigations: manage investigations related to deviations, nonconformances, out-of-spec events and complaints with root-cause analysis and proper documentation.
• Analyze Quality Data and Drive Improvements: monitor metrics, identify issues, and drive CAPAs to improve quality and operations.
• Cross-Functional Collaboration: work with Manufacturing, Operations, R&D, Supply Chain, and Quality; author and review reports and records.
• Support Compliance and Continuous Improvement: assist audits/inspections and lead QMS improvement projects.

Skills

Quality investigations

Data analysis

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in Engineering, Life Sciences, or related 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 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 Quality Engineer will provide quality engineering support for biomanufacturing operations, ensuring products are manufactured in compliance with applicable regulatory requirements, quality standards, and customer expectations. This critical role will lead and support investigations related to manufacturing deviations, nonconformances, and customer complaints, while partnering cross-functionally to identify root causes, implement corrective and preventive actions (CAPAs), and drive continuous improvement initiatives. The Quality Engineer will analyze quality data and trends, support risk management activities, and help maintain the effectiveness of the site's Quality Management System (QMS). This role will also serve as a key quality resource during audits, inspections, and customer visits.

This position reports to the Senior Manager, Quality Assurance and is part of the Quality Assurance department located in Logan, Utah, and will be an on-site role.

What you will do:

• Lead Quality Investigations: Lead and support investigations related to manufacturing deviations, nonconformances, out-of-specification events, and customer complaints, ensuring timely resolution, thorough root cause analysis, and high-quality documentation in compliance with QMS and regulatory requirements.

• Analyze Quality Data and Drive Improvements: Monitor and analyze quality metrics, trends, and process performance data; identify recurring issues, support risk assessments, and drive corrective and preventive actions (CAPAs) to improve product quality and operational effectiveness.

• Cross-Functional Collaboration: Partner with Manufacturing, Operations, R&D, Supply Chain, and Quality teams to support investigations, process validations, change controls, and continuous improvement initiatives; author and review technical reports, investigation records, and quality documentation.

• Support Compliance and Continuous Improvement: Serve as a quality engineering resource during internal and external audits, regulatory inspections, and customer visits; contribute to QMS enhancements and lead projects that strengthen compliance, reduce risk, and improve manufacturing performance.

Who you are:

• Education & Experience: Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or equivalent industry experience (minimum 5 years) in a GMP-regulated environment such as biopharmaceutical, biotechnology, medical device, or pharmaceutical manufacturing; at least 3 years of experience supporting investigations, CAPA, and quality systems activities.

• Technical & Regulatory Expertise: Strong knowledge of cGMP, ISO 9001/13485, and core QMS principles; experienced in audit readiness, documentation practices, and driving QMS improvements across cross-functional teams.

• Communication & Problem Solving: Demonstrated ability to manage multiple priorities in a fast-paced manufacturing environment; skilled in technical writing, data analysis, root cause investigation methodologies, and cross-functional collaboration, with a strong attention to detail and commitment to quality.

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.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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.

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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.

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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].