Quality Engineer – Sustaining Engineer
Core
Ensure product quality lifecycle from NPI to commercial operations, driving tech/design transfer, managing risk, and optimizing manufacturing/packaging processes for biopharma clients.
Role type
Senior IC Quality Engineer (Sustaining Engineering)
Builds
Sustainable engineering and commercial operations for medical device/combination products
Domain
Biopharma / Medical Devices / FDA Regulated Industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, risk management, process validation, supplier quality management, data analysis, technical writing, change assessment, control plan development, FMEA, measurement system analysis
Preferred skills
Lean Six Sigma, ASQ CQE, test method validation, sterilization processes, technical specifications development
Technologies
ERP, eQMS, MS Office, statistical software for data analysis
Responsibilities
Drive tech/design transfer with NPI, analyze incoming material variation, disposition non-conforming product, develop validation protocols and batch records, participate in supplier audits, support project acquisition and delivery, coach developing quality engineers
Seniority
Mid-Senior, hands-on IC
