Senior Quality Engineer - Combination Product
Core
Ensure compliance with cGMP requirements for drug-device combination therapies and support manufacturing operations.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Drug-device combination product manufacturing lines
Domain
Medical device / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, root cause analysis, statistical analysis, FMEA, quality audit execution, process monitoring, regulatory knowledge (21 CFR Part 4, 210, 211), Microsoft Excel, Minitab
Preferred skills
Technical leadership, cross-functional project management, external regulatory audit experience
Technologies
Microsoft Excel, Minitab
Responsibilities
Lead compliance and continuous improvement initiatives for combination product manufacturing; Serve as technical quality lead during internal and external audits; Analyze quality data to identify trends and drive corrective actions; Develop quality tools, training materials, and product quality plans; Lead cross-functional teams to reduce manufacturing defects; Support product containment activities and release criteria documentation; Evaluate effectiveness of quality systems against regulations.
Seniority
Senior, hands-on IC