Senior Engineer, Quality
Core
Senior Quality Engineer leading post-market risk assessments, failure analysis, and cross-functional quality reviews for therapeutic infusion products.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Therapeutic infusion products and associated manufacturing/quality processes
Domain
Healthcare / Medical Devices / Regulated Manufacturing
Required skills
Post-market risk assessment, failure analysis, CAPA management, audit support, R&D quality support, NPD/SPO development, ISO quality systems, regulatory compliance
Preferred skills
Cross-functional team facilitation, problem solving in ambiguous situations, business/cost implication analysis
Technologies
ISO standards, Quality Management Systems (QMS)
Responsibilities
Lead post-market risk assessments of product issues; lead product performance investigations via failure analysis; participate in cross-functional Complaint, Change Control, and CAPA Review Boards; support readiness for internal/external audits; provide quality support to R&D and laboratory studies; define scope of quality deliverables for new product development
Seniority
Senior, hands-on IC

