Quality Engineer

About the role

At Cytiva, one of Danaher’s operating companies, our work saves lives—and we’re united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where your unique viewpoint matters. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

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 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 position also serves as a key quality resource during audits, inspections, and customer visits.

Responsibilities

• 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.