Biopharma Quality Engineer – Investigations & CAPA Leader

Cytiva

Logan (UT)

On-site

USD 85,000 - 110,000

Full time

4 days ago

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Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

Cytiva in Logan, Utah, is seeking a Quality Engineer to provide quality engineering support for biomanufacturing, ensuring products meet regulatory requirements, quality standards, and customer expectations. This on-site role reports to the Senior Manager, Quality Assurance.

You will lead investigations related to deviations, nonconformances, and customer complaints, analyze data, drive CAPAs, and partner with Manufacturing, Operations, R&D, and Supply Chain to improve processes and the QMS.

Qualifications

GMP-regulated environment experience (5+ years).
Knowledge of cGMP, ISO 9001/13485, and QMS principles.
Experience with investigations, CAPA, and quality systems activities.

Responsibilities

Lead and support investigations related to deviations, nonconformances, OOS events, and customer complaints with root cause analysis.
Monitor quality metrics and drive CAPAs to improve product quality and operations.
Collaborate across Manufacturing, Operations, R&D, Supply Chain, and Quality on reports and documentation.
Support audits, regulatory inspections, and customer visits; strengthen the QMS.