Senior Quality Engineer
Core
Provide quality oversight and technical expertise for drug-device combination products, ensuring compliance with FDA regulations and global quality standards throughout the commercial lifecycle.
Role type
Senior Quality Engineer (Combination Product Operations)
Builds
Commercialized drug delivery systems and combination products
Domain
Biotechnology / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design History File management, Design Verification & Validation (V&V), Risk Management (ISO 14971, DFMEA, PFMEA), Statistical Process Control (SPC), Design of Experiments (DOE), Root Cause Analysis (8D, RCA), Change Control, CAPA management, GMP compliance, Lean and Six Sigma methodologies
Preferred skills
Reliability modeling, Performance trending, Engineering studies, Design transfer activities, Contract Manufacturing Organization (CMO) deliverables review
Technologies
CDOCS, TrackWise, BioConnect, ServiceNow, Smartsheet, Minitab
Responsibilities
Own and manage Design History Files, Design Trace Matrices, Control Plans, and design documentation; Lead and execute quality oversight for Design Verification & Validation activities; Review and approve Risk Management Files per ISO 14971; Review and approve IQ, OQ, and PQ validation documentation; Analyze quality and engineering data using Minitab for SPC and DOE; Support FDA inspections and ISO/MDSAP audits; Collaborate with R&D, Regulatory Affairs, Manufacturing, and suppliers to support commercial lifecycle management.
Seniority
Senior, hands-on IC
