Engineer II, Quality (Gul Circle)
Core
Ensure compliance with quality standards and regulatory requirements across manufacturing operations, including incoming inspection, IPQC testing, and batch record review.
Role type
Quality Engineer II (Manufacturing)
Builds
Array and instrument manufacturing products
Domain
Medical device / Biotech
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC, FTIR, UV Vis Spectrophotometer operation, cGMP, IVDR, ISO 13485 compliance, CAPA implementation, method validation, failure analysis, training junior staff
Preferred skills
People management, LEAN, 5S, Kaizen, VSM, RCCM
Technologies
Laboratory information management systems (LIMS), analytical laboratory equipment
Responsibilities
Perform incoming inspection and IPQC testing; review and disposition batch records; participate in method transfer and validation; conduct investigation and trending analyses; manage laboratory equipment and inventory; train and mentor junior staff
Seniority
Mid-level, hands-on IC
