Senior Quality Project Engineer
Core
Provide quality leadership for business-initiated projects including New Product Development, product sustainment, customization, innovation initiatives, and Transfer of Work activities to ensure quality, regulatory, and compliance requirements are integrated throughout the product and process lifecycle.
Role type
Senior Quality Project Engineer
Builds
New products, customized solutions, and transferred processes for life sciences, diagnostics, and biotechnology
Domain
Life sciences, diagnostics, biotechnology, GMP/ISO regulated industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality assurance principles, validation/qualification, project management, regulatory compliance, cross-functional team leadership, continuous improvement, quality-by-design
Preferred skills
ISO11137, ISO14644, ISO14698 knowledge, statistical improvement tools, lean manufacturing techniques
Technologies
ISO9001, ISO13485
Responsibilities
Provide quality oversight and guidance throughout design transfer, process development, verification, validation, and commercialization activities; Support successful transfer of products and processes from development to routine manufacturing; Partner with Product Management, RD&E, Manufacturing Engineering, Regulatory Affairs, Supply Chain, Supplier Quality, Global Sterility Assurance and Operations; Author, review, approve, and maintain validation protocols, reports, and other quality-related project documentation; Leverage complaint investigations, CAPAs, non-conformances, audit observations, and other quality data sources to drive continuous improvement
Seniority
Senior, hands-on IC
