Quality Engineer II
Core
Ensure compliance with quality standards and regulatory requirements across manufacturing operations, lead investigations, and implement corrective actions.
Role type
Quality Engineer II (GMP/ISO regulated environments)
Builds
Quality Management System (QMS), validated processes, audit-ready documentation
Domain
Life Sciences / Medical Devices / Pharmaceuticals / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/ISO regulated environment experience, root cause analysis, CAPA, change control, risk management (FMEA), internal/external audit support, statistical analysis, technical writing, data analysis
Preferred skills
ISO 13485/FDA Lead Auditor certification, ASQ certification (CQE/CQA), clean room environment experience, project management
Technologies
E1, SAP, Agile, TrackWise, Power BI, Excel, Visio, Teams, Word
Responsibilities
Support maintenance and continuous improvement of the Quality Management System (QMS), Perform quality review and approval of procedures and reports, Collaborate with cross-functional teams to implement robust quality control, Perform analysis of internal and external product quality data, Facilitate investigations and root cause analysis for customer complaints or deviations, Participate in internal, third-party, and agency inspections, Prepare audit reports, gap assessments, and meeting minutes
Seniority
Mid-level, hands-on IC
