Quality Engineer
Core
Lead quality investigations and drive continuous improvement for biomanufacturing operations to ensure regulatory compliance and product quality.
Role type
Quality Engineer (Biomanufacturing)
Builds
Biopharmaceutical products, medical devices, and cell/gene therapies
Domain
Life sciences / Biotechnology / Biomanufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, CAPA management, QMS maintenance, regulatory compliance (cGMP), data analysis, technical writing, cross-functional collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead investigations into manufacturing deviations, nonconformances, and customer complaints; Analyze quality metrics and trends to drive corrective actions; Partner with cross-functional teams on process validations and change controls; Serve as a resource during audits, inspections, and customer visits
Seniority
Mid-level, hands-on IC
